FDA.reportPublic FDA data

Gabapentin

Product NDC
68071-4978
11-digit product format
680714978
Labeler code
68071
Product ID
68071-4978_1b2ea4de-a23a-040d-e063-6394a90a49d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA206943
Marketing category
ANDA
Marketing start
2018-05-14
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

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
68071-4978-92021-02-19C16284748780-1ba0f9c33-1d27-a910-e053-dadaa90a0b85These 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
68071-4978-92021-01-29C16284748780-1ba0f9c33-1d27-a910-e053-dadaa90a0b85These 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
68071-4978-3Gabapentin30 in 1 BOTTLECAPSULE306
68071-4978-4Gabapentin40 in 1 BOTTLECAPSULE406
68071-4978-9Gabapentin90 in 1 BOTTLECAPSULE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4978GABAPENTIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 3 package rows20240619_8e6ed5d2-40e0-1f06-e053-2a95a90aa40e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN8e6ed5d2-40e0-1f06-e053-2a95a90aa40e6
310430gabapentin 100 MG Oral CapsuleSCD8e6ed5d2-40e0-1f06-e053-2a95a90aa40e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4978-36807149780330 CAPSULE in 1 BOTTLE (68071-4978-3) 30 capsule2019-07-24NoNoCurrent
68071-4978-46807149780440 CAPSULE in 1 BOTTLE (68071-4978-4) 40 capsule2019-07-24NoNoCurrent
68071-4978-96807149780990 CAPSULE in 1 BOTTLE (68071-4978-9) 90 capsule2019-07-240000-00-00NoNoCurrent