FDA.reportPublic FDA data

Gabapentin

Product NDC
50090-0896
11-digit product format
500900896
Labeler code
50090
Product ID
50090-0896_96a7580e-bd98-4869-9981-097278189351
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Substance
GABAPENTIN
Active strength
300 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310430, 310431, 310432

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
50090-0896-0Gabapentin100 in 1 BOTTLECAPSULE10044
50090-0896-1Gabapentin30 in 1 BOTTLECAPSULE3044
50090-0896-2Gabapentin60 in 1 BOTTLECAPSULE6044
50090-0896-3Gabapentin120 in 1 BOTTLECAPSULE12044
50090-0896-4Gabapentin90 in 1 BOTTLECAPSULE9044
50090-0896-5Gabapentin240 in 1 BOTTLECAPSULE24044
50090-0896-6Gabapentin270 in 1 BOTTLECAPSULE27044
50090-0896-7Gabapentin15 in 1 BOTTLECAPSULE1544
50090-0896-8Gabapentin42 in 1 BOTTLECAPSULE4244
50090-0896-9Gabapentin14 in 1 BOTTLECAPSULE1444

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0896-0EA - Each50090-0896325a5316-b4b9-4ef7-8153-bd8a7978993a12018-10-11
50090-0896-1EA - Each50090-08966389698e-8b4f-4c54-8373-89c820dbed5312018-10-11
50090-0896-2EA - Each50090-089631c109eb-98db-4dc9-9b25-a92556dfcafe12018-10-11
50090-0896-3EA - Each50090-08963e149836-bf1a-45e8-b84d-327600858d1f12018-10-11
50090-0896-4EA - Each50090-08967a088c8f-6841-4013-8caa-4bc3aed1a37b12018-10-11
50090-0896-5EA - Each50090-08960d4eb9bb-5f7f-47f1-96c3-715c8ed1272812018-10-11
50090-0896-6EA - Each50090-0896b0746d71-72b8-4240-97ce-403c59596ed312018-10-11
50090-0896-8EA - Each50090-08961a98946d-044a-46f0-b6bc-3d12d0c8bc0a12024-06-10
50090-0896-9EA - Each50090-08961bb945de-5e63-4fca-ba43-a374b4dfc26512024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0896GABAPENTIN CAPSULE [A-S MEDICATION SOLUTIONS]40Current NDC, Legacy NDC, 10 package rows20250417_03031adf-d36b-45ec-944e-dfce5a5de91a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSN03031adf-d36b-45ec-944e-dfce5a5de91a44
310431gabapentin 300 MG Oral CapsulePSN03031adf-d36b-45ec-944e-dfce5a5de91a44
310432gabapentin 400 MG Oral CapsulePSN03031adf-d36b-45ec-944e-dfce5a5de91a44
310430gabapentin 100 MG Oral CapsuleSCD03031adf-d36b-45ec-944e-dfce5a5de91a44
310431gabapentin 300 MG Oral CapsuleSCD03031adf-d36b-45ec-944e-dfce5a5de91a44
310432gabapentin 400 MG Oral CapsuleSCD03031adf-d36b-45ec-944e-dfce5a5de91a44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0896-050090089600100 CAPSULE in 1 BOTTLE (50090-0896-0) 100 capsule2014-11-280000-00-00NoNoCurrent
50090-0896-15009008960130 CAPSULE in 1 BOTTLE (50090-0896-1) 30 capsule2014-11-280000-00-00NoNoCurrent
50090-0896-25009008960260 CAPSULE in 1 BOTTLE (50090-0896-2) 60 capsule2014-11-280000-00-00NoNoCurrent
50090-0896-350090089603120 CAPSULE in 1 BOTTLE (50090-0896-3) 120 capsule2014-11-280000-00-00NoNoCurrent
50090-0896-45009008960490 CAPSULE in 1 BOTTLE (50090-0896-4) 90 capsule2014-11-280000-00-00NoNoCurrent
50090-0896-550090089605240 CAPSULE in 1 BOTTLE (50090-0896-5) 240 capsule2014-11-280000-00-00NoNoCurrent
50090-0896-650090089606270 CAPSULE in 1 BOTTLE (50090-0896-6) 270 capsule2017-10-240000-00-00NoNoCurrent
50090-0896-75009008960715 CAPSULE in 1 BOTTLE (50090-0896-7) 15 capsule2018-08-070000-00-00NoNoCurrent
50090-0896-85009008960842 CAPSULE in 1 BOTTLE (50090-0896-8) 42 capsule2024-05-15NoNoHistorical
50090-0896-95009008960914 CAPSULE in 1 BOTTLE (50090-0896-9) 14 capsule2024-06-18NoNoHistorical