FDA.reportPublic FDA data

Gabapentin

Product NDC
72162-2139
11-digit product format
721622139
Labeler code
72162
Product ID
72162-2139_8513f8ab-cf2a-4654-b0b3-91640b319168
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206943
Marketing category
ANDA
Marketing start
2018-05-14
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
Rxcui310431

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
72162-2139-1Gabapentin100 in 1 BOTTLE, PLASTICCAPSULE100104
72162-2139-2Gabapentin270 in 1 BOTTLE, PLASTICCAPSULE270104
72162-2139-3Gabapentin30 in 1 BOTTLE, PLASTICCAPSULE30104
72162-2139-5Gabapentin500 in 1 BOTTLE, PLASTICCAPSULE500104
72162-2139-9Gabapentin90 in 1 BOTTLE, PLASTICCAPSULE90104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2139-2EA - Each72162-2139959de511-1021-424c-a488-7c80b2e5c31612024-08-12
72162-2139-3EA - Each72162-213929a74d58-02c3-42ba-81b6-676eecd6227f12024-12-10
72162-2139-5EA - Each72162-2139864bc7d6-425f-4ffb-8d01-2f06fab2cdc112024-02-14
72162-2139-9EA - Each72162-213929bb6581-6045-4996-a5de-c1970517301112024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2139GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]104Current NDC, 5 package rows20241020_fb0b6613-57d6-4e24-946f-f5f87c460cf0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSNfb0b6613-57d6-4e24-946f-f5f87c460cf0104
310431gabapentin 300 MG Oral CapsuleSCDfb0b6613-57d6-4e24-946f-f5f87c460cf0104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2139-172162213901100 CAPSULE in 1 BOTTLE, PLASTIC (72162-2139-1) 100 capsule2023-10-12NoNoCurrent
72162-2139-272162213902270 CAPSULE in 1 BOTTLE, PLASTIC (72162-2139-2) 270 capsule2023-10-12NoNoCurrent
72162-2139-37216221390330 CAPSULE in 1 BOTTLE, PLASTIC (72162-2139-3) 30 capsule2023-10-12NoNoCurrent
72162-2139-572162213905500 CAPSULE in 1 BOTTLE, PLASTIC (72162-2139-5) 500 capsule2023-10-12NoNoCurrent
72162-2139-97216221390990 CAPSULE in 1 BOTTLE, PLASTIC (72162-2139-9) 90 capsule2023-10-12NoNoCurrent