FDA.reportPublic FDA data

GABAPENTIN

Product NDC
70518-2919
11-digit product format
705182919
Labeler code
70518
Product ID
70518-2919_4ab8d0dd-0947-3d29-e063-6294a90ab17a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090007
Marketing category
ANDA
Marketing start
2020-10-23
Substance
GABAPENTIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2919-02023-03-13C16284748780-1f386c64a-35d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
70518-2919-02023-01-30C16284748780-1f386c64a-35d5-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2919-0GABAPENTIN30 in 1 BLISTER PACKCAPSULE304
70518-2919-1GABAPENTIN30 in 1 BLISTER PACKCAPSULE304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN915cee37-536c-4761-bdb9-b96c7ee0f9564
310432gabapentin 400 MG Oral CapsuleSCD915cee37-536c-4761-bdb9-b96c7ee0f9564

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2919-07051829190030 CAPSULE in 1 BLISTER PACK (70518-2919-0) 30 capsule2020-10-230000-00-00NoNoCurrent
70518-2919-17051829190130 CAPSULE in 1 BLISTER PACK (70518-2919-1) 30 capsule2025-08-14NoNoHistorical