National Drug Code Packages

$199 / year

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. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360)). 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. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.

Complexity

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)

Date Created

2012

Last Modified

2018-10-30

Version

2018-10-30

Update Frequency

Daily

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs => US Food and Drug Administration (FDA)

Source License URL

John Snow Labs Standard License

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

Name Description Type Constraints
Product_IDProductID 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.stringrequired : 1
Product_NDCThe 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.stringrequired : 1 maxLength : 10
NDC_Package_CodeThe 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.stringrequired : 1 maxLength : 12
Package_DescriptionA 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.stringrequired : 1
Start_Marketing_DateThis is the date that the labeler indicates was the start of its marketing of the drug productdate-
End_Marketing_DateThis 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_FlagThis 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_PackageThis indicates whether a sample package has been submitted as part of the FDA submission.boolean-
Product_IDProduct_NDCNDC_Package_CodePackage_DescriptionStart_Marketing_DateEnd_Marketing_DateIs_NDC_Exclude_FlagIs_Sample_Package
65952-575_bfe45b6f-c017-4514-9e29-6391641b92f665952-57565952-575-13800 mL in 1 BAG (65952-575-13) falsefalse
68654-575_4a118beb-d5e9-4aee-9f0a-b5cdc6190c8d68654-57568654-575-13800 mL in 1 BAG (68654-575-13) falsefalse
65952-575_bfe45b6f-c017-4514-9e29-6391641b92f665952-57565952-575-121000 mL in 1 BAG (65952-575-12) falsefalse
68654-575_4a118beb-d5e9-4aee-9f0a-b5cdc6190c8d68654-57568654-575-121000 mL in 1 BAG (68654-575-12) falsefalse
65952-575_bfe45b6f-c017-4514-9e29-6391641b92f665952-57565952-575-55208200 mL in 1 DRUM (65952-575-55) falsefalse
68654-575_4a118beb-d5e9-4aee-9f0a-b5cdc6190c8d68654-57568654-575-55208200 mL in 1 DRUM (68654-575-55) falsefalse
64942-1100_a5e0d1b9-7ae9-4664-be9c-3482804ec49664942-110064942-1100-176 g in 1 CONTAINER (64942-1100-1) falsefalse
64942-1100_a5e0d1b9-7ae9-4664-be9c-3482804ec49664942-110064942-1100-214 g in 1 CONTAINER (64942-1100-2) falsefalse
64942-1100_a5e0d1b9-7ae9-4664-be9c-3482804ec49664942-110064942-1100-348 g in 1 CONTAINER (64942-1100-3) falsefalse
64942-1101_c26632da-38f0-4d52-a323-a07adc444c1064942-110164942-1101-114 g in 1 CONTAINER (64942-1101-1) falsefalse