FDA.reportPublic FDA data

Gabapentin

Product NDC
72789-127
11-digit product format
727890127
Labeler code
72789
Product ID
72789-127_4d515374-ab61-d0f9-e063-6294a90ab3f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078926
Marketing category
ANDA
Marketing start
2012-10-16
Substance
GABAPENTIN
Active strength
600 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
GABAPENTIN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310433

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
72789-127-90Gabapentin90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-127GABAPENTIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 1 package rows20241003_81774da8-cb1d-4c7d-8550-35396850d5ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN81774da8-cb1d-4c7d-8550-35396850d5ff21
310433gabapentin 600 MG Oral TabletSCD81774da8-cb1d-4c7d-8550-35396850d5ff21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-127-307278901273030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-127-30) 2020-09-250000-00-00NoNoCurrent
72789-127-907278901279090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-127-90) 2022-12-010000-00-00NoNoCurrent