FDA.reportPublic FDA data

Gabapentin

Product NDC
69434-042
11-digit product format
694340042
Labeler code
69434
Product ID
69434-042_457c0aa0-f1e5-d420-e063-6294a90a6d40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Zhejiang Yongtai Pharmaceutical Co., Ltd
Application
ANDA213603
Marketing category
ANDA
Marketing start
2025-12-03
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

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
69434-042-032024-12-12C16284748780-1f386c64a-10b2-0266-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
69434-042-042024-12-12C16284748780-1f386c64a-10b2-0266-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
69434-042-032023-01-30C16284748780-1f386c64a-10b2-0266-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
69434-042-042023-01-30C16284748780-1f386c64a-10b2-0266-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
69434-042-03Gabapentin500 in 1 BOTTLECAPSULE50014
69434-042-04Gabapentin100 in 1 BOTTLECAPSULE10014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69434-042GABAPENTIN CAPSULE [ZHEJIANG YONGTAI PHARMACEUTICAL CO., LTD]12Current NDC, Legacy NDC, 2 package rows20250216_f1eda6cc-d9b2-4df4-a09b-20eebded760f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNf1eda6cc-d9b2-4df4-a09b-20eebded760f14
310431gabapentin 300 MG Oral CapsulePSNf1eda6cc-d9b2-4df4-a09b-20eebded760f14
310432gabapentin 400 MG Oral CapsulePSNf1eda6cc-d9b2-4df4-a09b-20eebded760f14
310430gabapentin 100 MG Oral CapsuleSCDf1eda6cc-d9b2-4df4-a09b-20eebded760f14
310431gabapentin 300 MG Oral CapsuleSCDf1eda6cc-d9b2-4df4-a09b-20eebded760f14
310432gabapentin 400 MG Oral CapsuleSCDf1eda6cc-d9b2-4df4-a09b-20eebded760f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69434-042-0369434004203500 CAPSULE in 1 BOTTLE (69434-042-03) 500 capsule2025-12-030000-00-00NoNoCurrent
69434-042-0469434004204100 CAPSULE in 1 BOTTLE (69434-042-04) 100 capsule2025-12-030000-00-00NoNoCurrent