GABAPENTIN

Product NDC
72865-256
11-digit product format
728650256
Labeler code
72865
Product ID
72865-256_96acc27b-7400-480e-b79a-baa8ac3ab801
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
XLCare Pharmaceuticals, Inc.
Application
ANDA214957
Marketing category
ANDA
Marketing start
2021-10-01
Substance
GABAPENTIN
Active strength
800 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
GABAPENTIN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433, 310434

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
72865-256-05GABAPENTIN500 in 1 BOTTLETABLET5002
72865-256-90GABAPENTIN90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72865-256GABAPENTIN TABLET [XLCARE PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20231122_707ed63a-67ca-4a62-9cbe-cdeb5c4ab506.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN707ed63a-67ca-4a62-9cbe-cdeb5c4ab5062
310434gabapentin 800 MG Oral TabletPSN707ed63a-67ca-4a62-9cbe-cdeb5c4ab5062
310433gabapentin 600 MG Oral TabletSCD707ed63a-67ca-4a62-9cbe-cdeb5c4ab5062
310434gabapentin 800 MG Oral TabletSCD707ed63a-67ca-4a62-9cbe-cdeb5c4ab5062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-256-0572865025605500 TABLET in 1 BOTTLE (72865-256-05) 500 tablet2021-10-01NoNoCurrent
72865-256-907286502569090 TABLET in 1 BOTTLE (72865-256-90) 90 tablet2021-10-01NoNoCurrent