Gabapentin

Product NDC
69367-345
11-digit product format
693670345
Labeler code
69367
Product ID
69367-345_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
400 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
GABAPENTIN400 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-345-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-345-05EA - Each69367-345aff9581d-b3be-4053-85b9-23554970ff0312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-345GABAPENTIN 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
310430gabapentin 100 MG Oral CapsulePSN3ad96553-73a4-4a9b-8a89-10a29b794ed34
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 CapsuleSCD3ad96553-73a4-4a9b-8a89-10a29b794ed34
310432gabapentin 400 MG Oral CapsuleSCD3ad96553-73a4-4a9b-8a89-10a29b794ed34
310432gabapentin 400 MG Oral CapsulePSNf781d400-7304-5d3e-e053-6294a90ac5722
310432gabapentin 400 MG Oral CapsuleSCDf781d400-7304-5d3e-e053-6294a90ac5722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-345-0569367034505500 CAPSULE in 1 BOTTLE, PLASTIC (69367-345-05) 500 capsule2021-11-010000-00-00NoNoCurrent