FDA.reportPublic FDA data

Gabapentin

Product NDC
72189-524
11-digit product format
721890524
Labeler code
72189
Product ID
72189-524_4c4aa699-bcdb-17b5-e063-6294a90a2c05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA207099
Marketing category
ANDA
Marketing start
2023-11-27
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
Rxcui310432

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-524-30Gabapentin30 in 1 BOTTLECAPSULE304
72189-524-60Gabapentin60 in 1 BOTTLECAPSULE604
72189-524-72Gabapentin120 in 1 BOTTLECAPSULE1204
72189-524-90Gabapentin90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-524-30EA - Each72189-5244aa31dd3-0f68-4237-9982-37a3c483019012025-05-14
72189-524-60EA - Each72189-524b7b9fcd2-5f4f-44a2-a869-5501b8a9008812024-10-04
72189-524-90EA - Each72189-52461cbe638-dae8-447c-b0d4-002e0d37d49d12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-524GABAPENTIN CAPSULE [DIRECT_RX]3Current NDC, 4 package rows20250311_0b286fd1-8179-d87a-e063-6294a90a2f23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310432gabapentin 400 MG Oral CapsulePSN0b286fd1-8179-d87a-e063-6294a90a2f234
310432gabapentin 400 MG Oral CapsuleSCD0b286fd1-8179-d87a-e063-6294a90a2f234

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72189-524-307218905243030 CAPSULE in 1 BOTTLE (72189-524-30) 30 capsule2023-11-27NoNoHistorical
72189-524-607218905246060 CAPSULE in 1 BOTTLE (72189-524-60) 60 capsule2023-11-27NoNoHistorical
72189-524-7272189052472120 CAPSULE in 1 BOTTLE (72189-524-72) 120 capsule2023-11-27NoNoHistorical
72189-524-907218905249090 CAPSULE in 1 BOTTLE (72189-524-90) 90 capsule2023-11-27NoNoHistorical