Gabapentin

Product NDC
69367-344
11-digit product format
693670344
Labeler code
69367
Product ID
69367-344_e369733c-4898-4f60-9499-db7c27a2f3c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA075477
Marketing category
ANDA
Marketing start
2021-11-01
Substance
GABAPENTIN
Active strength
300 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
GABAPENTIN300 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-344-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-344-05EA - Each69367-344f906bed7-ab8d-4a70-b7d7-7e2e8b787bc212022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-344GABAPENTIN CAPSULE [WESTMINSTER PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20250409_3ad96553-73a4-4a9b-8a89-10a29b794ed3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNebf57adf-b066-2959-e053-2a95a90a961c5
310431gabapentin 300 MG Oral CapsuleSCDebf57adf-b066-2959-e053-2a95a90a961c5
310430gabapentin 100 MG Oral CapsulePSN3ad96553-73a4-4a9b-8a89-10a29b794ed34
310431gabapentin 300 MG Oral CapsulePSN0919fed8-e968-b5ac-e063-6294a90afbff4
310431gabapentin 300 MG Oral CapsulePSN3ad96553-73a4-4a9b-8a89-10a29b794ed34
310432gabapentin 400 MG Oral CapsulePSN3ad96553-73a4-4a9b-8a89-10a29b794ed34
310430gabapentin 100 MG Oral CapsuleSCD3ad96553-73a4-4a9b-8a89-10a29b794ed34
310431gabapentin 300 MG Oral CapsuleSCD0919fed8-e968-b5ac-e063-6294a90afbff4
310431gabapentin 300 MG Oral CapsuleSCD3ad96553-73a4-4a9b-8a89-10a29b794ed34
310432gabapentin 400 MG Oral CapsuleSCD3ad96553-73a4-4a9b-8a89-10a29b794ed34
310431gabapentin 300 MG Oral CapsulePSN3c8dca11-78ab-45c1-8bb2-89a41ea5dfa91
310431gabapentin 300 MG Oral CapsuleSCD3c8dca11-78ab-45c1-8bb2-89a41ea5dfa91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-344-0569367034405500 CAPSULE in 1 BOTTLE, PLASTIC (69367-344-05) 500 capsule2021-11-010000-00-00NoNoCurrent