FDA.reportPublic FDA data

Gabapentin

Product NDC
50090-0949
11-digit product format
500900949
Labeler code
50090
Product ID
50090-0949_bf9abed3-bc5b-4606-831d-1ae78cdea91d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078787
Marketing category
ANDA
Marketing start
2008-01-31
Substance
GABAPENTIN
Active strength
100 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
GABAPENTIN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430

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
50090-0949-0Gabapentin30 in 1 BOTTLECAPSULE3013
50090-0949-1Gabapentin100 in 1 BOTTLECAPSULE10013
50090-0949-2Gabapentin90 in 1 BOTTLECAPSULE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0949-0EA - Each50090-094902e62494-1b2a-4416-bd28-d5d0ab13da5a12018-10-11
50090-0949-1EA - Each50090-0949e330aeef-cf26-467c-867f-3e29cb123ade12018-10-11
50090-0949-2EA - Each50090-09496cf3b2f8-afd8-4ed5-8a6e-4cbb0435a26612022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0949GABAPENTIN CAPSULE [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 3 package rows20231210_ecb798a0-377d-4712-bb82-ec9d7116962f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNecb798a0-377d-4712-bb82-ec9d7116962f13
310430gabapentin 100 MG Oral CapsuleSCDecb798a0-377d-4712-bb82-ec9d7116962f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0949-05009009490030 CAPSULE in 1 BOTTLE (50090-0949-0) 30 capsule2014-11-280000-00-00NoNoCurrent
50090-0949-150090094901100 CAPSULE in 1 BOTTLE (50090-0949-1) 100 capsule2014-11-280000-00-00NoNoCurrent
50090-0949-25009009490290 CAPSULE in 1 BOTTLE (50090-0949-2) 90 capsule2014-11-280000-00-00NoNoCurrent