FDA.reportPublic FDA data

Gabapentin

Product NDC
50090-6854
11-digit product format
500906854
Labeler code
50090
Product ID
50090-6854_38b796d8-75a7-4fef-9e33-0adaca3de95e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA200651
Marketing category
ANDA
Marketing start
2011-10-06
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6854-0Gabapentin90 in 1 BOTTLETABLET, FILM COATED903
50090-6854-1Gabapentin60 in 1 BOTTLETABLET, FILM COATED603
50090-6854-2Gabapentin30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6854-0EA - Each50090-6854dcc0059f-b77f-4ace-a11d-5539ad1d33d812024-02-14
50090-6854-1EA - Each50090-685429eeab34-60ad-4778-8c56-049775ef11e112024-02-14
50090-6854-2EA - Each50090-68543ba00d5d-f791-402e-9c41-85e19e80da1812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6854GABAPENTIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20231205_0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d3
310433gabapentin 600 MG Oral TabletSCD0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6854-05009068540090 TABLET, FILM COATED in 1 BOTTLE (50090-6854-0) 2023-11-30NoNoHistorical
50090-6854-15009068540160 TABLET, FILM COATED in 1 BOTTLE (50090-6854-1) 2023-11-30NoNoHistorical
50090-6854-25009068540230 TABLET, FILM COATED in 1 BOTTLE (50090-6854-2) 2023-11-30NoNoHistorical