Gabapentin

Product NDC
0904-7615
11-digit product format
009047615
Labeler code
0904
Product ID
0904-7615_999f3685-2eac-467e-bed2-1d0c36aaf0ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090858
Marketing category
ANDA
Marketing start
2026-04-27
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
0904-7615-61Gabapentin1 in 1 BLISTER PACKCAPSULE11
0904-7615-61Gabapentin100 in 1 CARTONCAPSULE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7615-61EA - Each0904-7615edf29e1c-37ea-4f2a-bf29-47800324b8b812026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN999f3685-2eac-467e-bed2-1d0c36aaf0ed1
310431gabapentin 300 MG Oral CapsulePSN999f3685-2eac-467e-bed2-1d0c36aaf0ed1
310432gabapentin 400 MG Oral CapsulePSN999f3685-2eac-467e-bed2-1d0c36aaf0ed1
310430gabapentin 100 MG Oral CapsuleSCD999f3685-2eac-467e-bed2-1d0c36aaf0ed1
310431gabapentin 300 MG Oral CapsuleSCD999f3685-2eac-467e-bed2-1d0c36aaf0ed1
310432gabapentin 400 MG Oral CapsuleSCD999f3685-2eac-467e-bed2-1d0c36aaf0ed1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7615-6100904761561100 BLISTER PACK in 1 CARTON (0904-7615-61) / 1 CAPSULE in 1 BLISTER PACK100 blister pack2026-04-27NoNoHistorical