FDA.reportPublic FDA data

Gabapentin

Product NDC
50090-7268
11-digit product format
500907268
Labeler code
50090
Product ID
50090-7268_99ca59f5-5122-47e7-90fc-a0077f0ac0f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207057
Marketing category
ANDA
Marketing start
2021-11-01
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
50090-7268-0Gabapentin90 in 1 BOTTLETABLET, COATED903
50090-7268-1Gabapentin60 in 1 BOTTLETABLET, COATED603
50090-7268-2Gabapentin30 in 1 BOTTLETABLET, COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7268-0EA - Each50090-726869af5052-5754-405c-b33a-de753315604d12024-11-05
50090-7268-1EA - Each50090-72688da615cb-8cc2-491f-b7e4-ce3f4a4572fc12024-11-05
50090-7268-2EA - Each50090-7268547364ab-cd2b-4d77-961d-a6c78ef6a1fc12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7268GABAPENTIN TABLET, COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 3 package rows20241012_b88b0cbc-c883-4d17-8f46-0e5bddc57835.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSNb88b0cbc-c883-4d17-8f46-0e5bddc578353
310433gabapentin 600 MG Oral TabletSCDb88b0cbc-c883-4d17-8f46-0e5bddc578353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7268-05009072680090 TABLET, COATED in 1 BOTTLE (50090-7268-0) 2024-10-08NoNoHistorical
50090-7268-15009072680160 TABLET, COATED in 1 BOTTLE (50090-7268-1) 2024-10-08NoNoHistorical
50090-7268-25009072680230 TABLET, COATED in 1 BOTTLE (50090-7268-2) 2024-10-08NoNoHistorical