FDA.reportPublic FDA data

Pregabalin

Product NDC
50090-5038
11-digit product format
500905038
Labeler code
50090
Product ID
50090-5038_ec6d3b8b-92b8-4def-98cb-ee905069cb64
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PREGABALIN
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208677
Marketing category
ANDA
Marketing start
2019-07-19
Substance
PREGABALIN
Active strength
75 mg/1
DEA schedule
CV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pregabalin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PREGABALIN75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii55JG375S6M
Rxcui483450

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
441d8579-bd15-4585-93f4-9de3db2d851dProduct name420251114
004d1029-ec13-fc89-74f4-3907cf5b6602Product name220140523

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5038-02023-02-07C16284748780-1f386c64a-219e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004
50090-5038-02023-01-30C16284748780-1f386c64a-219e-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use PREGABALIN CAPSULES safely and effectively. See full prescribing information for PREGABALIN CAPSULES. PREGABALIN capsules for oral use, CV Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5038-0Pregabalin90 in 1 BOTTLECAPSULE9011
50090-5038-1Pregabalin60 in 1 BOTTLECAPSULE6011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5038PREGABALIN CAPSULE [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20241024_55b62778-0e6a-45e8-9ace-3f1d6eca4487.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
483450pregabalin 75 MG Oral CapsulePSN55b62778-0e6a-45e8-9ace-3f1d6eca448711
483450pregabalin 75 MG Oral CapsuleSCD55b62778-0e6a-45e8-9ace-3f1d6eca448711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5038-05009050380090 CAPSULE in 1 BOTTLE (50090-5038-0) 90 capsule2020-05-080000-00-00NoNoCurrent
50090-5038-15009050380160 CAPSULE in 1 BOTTLE (50090-5038-1) 60 capsule2024-10-22NoNoCurrent