Gabapentin

Product NDC
76420-789
11-digit product format
764200789
Labeler code
76420
Product ID
76420-789_227219b4-ec12-cb15-e063-6394a90acd32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA204989
Marketing category
ANDA
Marketing start
2016-02-18
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
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-789-01Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE1003
76420-789-05Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE5003
76420-789-12Gabapentin120 in 1 BOTTLE, PLASTICCAPSULE1203
76420-789-30Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE303
76420-789-60Gabapentin60 in 1 BOTTLE, PLASTICCAPSULE603
76420-789-90Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-789GABAPENTIN CAPSULE [ASCLEMED USA, INC.]3Current NDC, 6 package rows20240921_9a829dc3-b2d8-4d19-a579-0597217cec9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310431gabapentin 300 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310432gabapentin 400 MG Oral CapsulePSN9a829dc3-b2d8-4d19-a579-0597217cec9b3
310430gabapentin 100 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310431gabapentin 300 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3
310432gabapentin 400 MG Oral CapsuleSCD9a829dc3-b2d8-4d19-a579-0597217cec9b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-789-0176420078901100 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-01) 100 capsule2024-03-30NoNoHistorical
76420-789-0576420078905500 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-05) 500 capsule2024-03-30NoNoHistorical
76420-789-1276420078912120 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-12) 120 capsule2024-09-17NoNoHistorical
76420-789-307642007893030 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-30) 30 capsule2024-03-30NoNoHistorical
76420-789-607642007896060 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-60) 60 capsule2024-03-30NoNoHistorical
76420-789-907642007899090 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-90) 90 capsule2024-03-30NoNoHistorical