Others titles
- National Drug Code Directory
- NDC codes, NDC packages
Keywords
- NDC Database
- NDC Lookup
- NDC Number
- Drug Description Identifier
National Drug Code Packages
The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution including drug code packages. Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs.
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Description
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA in SPL electronic listing files by labelers. (A labeler may be either a manufacturer, including a repackager or relabeler, or, for drugs subject to private labeling arrangements, the entity under whose own label or trade name the product will be distributed.) Inclusion of information in the NDC Directory does not indicate that FDA has verified the information provided. The content of each NDC Directory entry is the responsibility of the labeler submitting the SPL file. Assignment of an NDC number does not in any way denote FDA approval of the product. Any representation that creates an impression of official approval because of possession of an NDC number is misleading and constitutes misbranding. (21 CFR 207.39) FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.(See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)).
About this Dataset
Data Info
Date Created | 2012 |
---|---|
Last Modified | 2024-04-24 |
Version | 2024-04-24 |
Update Frequency |
Daily |
Temporal Coverage |
N/A |
Spatial Coverage |
United States |
Source | John Snow Labs; US Food and Drug Administration (FDA); |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | NDC Database, NDC Lookup, NDC Number, Drug Description Identifier |
Other Titles | National Drug Code Directory, NDC codes, NDC packages |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Product_ID | ProductID is a concatenation of the NDCproduct code and SPL documentID. It is included to help prevent duplicate rows from appearing when joining the product and package files together. It has no regulatory value or significance. | string | - |
Product_NDC | The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. | string | - |
NDC_Package_Code | The labeler code, product code, and package code segments of the National Drug Code number, separated by hyphens. Asterisks are no longer used or included within the product and package code segments to indicate certain configurations of the NDC. | string | - |
Package_Description | A description of the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. For example: 4 Bottles in 1 Carton/100 Tablets in 1 Bottle. | string | - |
Start_Marketing_Date | This is the date that the labeler indicates was the start of its marketing of the drug product | date | - |
End_Marketing_Date | This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the End Marketing Date, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any End Marketing Date. Products with a value in the End Marketing Date will be removed from the NDC Directory when the End Marketing Date is reached. | date | - |
Is_NDC_Exclude_Flag | This indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. | boolean | - |
Is_Sample_Package | This indicates whether a sample package has been submitted as part of the FDA submission. | boolean | - |
Data Preview
Product ID | Product NDC | NDC Package Code | Package Description | Start Marketing Date | End Marketing Date | Is NDC Exclude Flag | Is Sample Package |
0002-0152_1761b768-7da0-44a9-bded-54c3bc63414a | 0002-0152 | 0002-0152-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-01) / .5 mL in 1 VIAL, SINGLE-DOSE | 2024-03-28 | False | False | |
0002-0213_458ef2aa-cd5f-48bc-8829-82420cfed33b | 0002-0213 | 0002-0213-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (0002-0213-01) / 3 mL in 1 VIAL, MULTI-DOSE | 2023-06-20 | False | False | |
0002-0243_1761b768-7da0-44a9-bded-54c3bc63414a | 0002-0243 | 0002-0243-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0243-01) / .5 mL in 1 VIAL, SINGLE-DOSE | 2024-03-28 | False | False | |
0002-0800_dec32ead-837e-4331-ab55-f3bbccea5b38 | 0002-0800 | 0002-0800-01 | 1 VIAL in 1 CARTON (0002-0800-01) / 10 mL in 1 VIAL | 1987-07-10 | False | False | |
0002-1152_b597917f-9673-4331-809d-79a538bb943c | 0002-1152 | 0002-1152-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-1152-01) / .5 mL in 1 VIAL, SINGLE-DOSE | 2023-07-28 | False | False | |
0002-1200_c2f899b5-287a-4002-ae37-f69418174eb4 | 0002-1200 | 0002-1200-48 | 1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-48) / 100 mL in 1 VIAL, MULTI-DOSE | 2023-05-22 | False | False | |
0002-1200_c2f899b5-287a-4002-ae37-f69418174eb4 | 0002-1200 | 0002-1200-50 | 1 VIAL, MULTI-DOSE in 1 CAN (0002-1200-50) / 50 mL in 1 VIAL, MULTI-DOSE | 2012-06-01 | False | False | |
0002-1214_1761b768-7da0-44a9-bded-54c3bc63414a | 0002-1214 | 0002-1214-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-1214-01) / .5 mL in 1 VIAL, SINGLE-DOSE | 2024-03-28 | False | False | |
0002-1220_f615e11a-4b7c-4d64-99d2-36bc282fa391 | 0002-1220 | 0002-1220-48 | 1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-48) / 100 mL in 1 VIAL, MULTI-DOSE | 2022-10-25 | False | False | |
0002-1220_f615e11a-4b7c-4d64-99d2-36bc282fa391 | 0002-1220 | 0002-1220-50 | 1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-50) / 50 mL in 1 VIAL, MULTI-DOSE | 2022-10-25 | False | False |