Gabapentin

Product NDC
0480-3494
11-digit product format
004803494
Labeler code
0480
Product ID
0480-3494_157f7b80-eebd-4199-b190-3a5a99276f13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA075350
Marketing category
ANDA
Marketing start
2026-01-12
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431

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
0480-3494-05Gabapentin500 in 1 BOTTLECAPSULE5002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-3494-05EA - Each0480-3494738597af-3e0e-466d-ab52-8e3281f5a56a12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNc7f21eaa-68ee-420c-9c98-e997cc73a2972
310431gabapentin 300 MG Oral CapsulePSNc7f21eaa-68ee-420c-9c98-e997cc73a2972
310430gabapentin 100 MG Oral CapsuleSCDc7f21eaa-68ee-420c-9c98-e997cc73a2972
310431gabapentin 300 MG Oral CapsuleSCDc7f21eaa-68ee-420c-9c98-e997cc73a2972

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-3494-0500480349405500 CAPSULE in 1 BOTTLE (0480-3494-05) 500 capsule2026-01-12NoNoHistorical