Gabapentin

Product NDC
43547-481
11-digit product format
435470481
Labeler code
43547
Product ID
43547-481_360d953b-4313-45ae-b933-296547d4577d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Solco Healthcare US, LLC
Application
ANDA219814
Marketing category
ANDA
Marketing start
2026-04-29
Substance
GABAPENTIN
Active strength
400 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
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
43547-481-10Gabapentin100 in 1 BOTTLECAPSULE1001
43547-481-50Gabapentin500 in 1 BOTTLECAPSULE5001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN360d953b-4313-45ae-b933-296547d4577d1
310431gabapentin 300 MG Oral CapsulePSN360d953b-4313-45ae-b933-296547d4577d1
310432gabapentin 400 MG Oral CapsulePSN360d953b-4313-45ae-b933-296547d4577d1
310430gabapentin 100 MG Oral CapsuleSCD360d953b-4313-45ae-b933-296547d4577d1
310431gabapentin 300 MG Oral CapsuleSCD360d953b-4313-45ae-b933-296547d4577d1
310432gabapentin 400 MG Oral CapsuleSCD360d953b-4313-45ae-b933-296547d4577d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43547-481-1043547048110100 CAPSULE in 1 BOTTLE (43547-481-10) 100 capsule2026-04-29NoNoCurrent
43547-481-5043547048150500 CAPSULE in 1 BOTTLE (43547-481-50) 500 capsule2026-04-29NoNoCurrent