Gabapentin

Product NDC
33261-048
11-digit product format
332610048
Labeler code
33261
Product ID
33261-048_aeb1540b-a797-44b1-9964-28ddfba18b4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078428
Marketing category
ANDA
Marketing start
2009-11-24
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
100 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-048-00Gabapentin100 in 1 BOTTLECAPSULE1003
33261-048-02Gabapentin120 in 1 BOTTLECAPSULE1203
33261-048-10Gabapentin10 in 1 BOTTLECAPSULE103
33261-048-20Gabapentin20 in 1 BOTTLECAPSULE203
33261-048-21Gabapentin21 in 1 BOTTLECAPSULE213
33261-048-30Gabapentin30 in 1 BOTTLECAPSULE303
33261-048-45Gabapentin45 in 1 BOTTLECAPSULE453
33261-048-60Gabapentin60 in 1 BOTTLECAPSULE603
33261-048-81Gabapentin81 in 1 BOTTLECAPSULE813
33261-048-90Gabapentin90 in 1 BOTTLECAPSULE903
33261-048-97Gabapentin126 in 1 BOTTLECAPSULE1263
33261-048-99Gabapentin180 in 1 CAPSULECAPSULE1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-048-00EA - Each33261-048c49b535f-fff9-41d9-9f7b-f38f60c79e9712015-10-02
33261-048-02EA - Each33261-048960f1e0a-1b57-461d-8064-7754c6bae48312015-10-02
33261-048-10EA - Each33261-04830870c5f-5c55-471d-8016-a3893f45b58212015-10-02
33261-048-20EA - Each33261-048c8a1459c-2eae-4300-afd3-74a393b3f95c12015-10-02
33261-048-21EA - Each33261-048bbcd197c-ecc8-49b9-9f0c-d10800a8bb9b12015-10-02
33261-048-30EA - Each33261-0480c3143f4-265b-4e6e-bfde-dc12306ef11d12015-10-02
33261-048-45EA - Each33261-0484b78e464-28bb-4505-ba35-945089d11a1b12015-10-02
33261-048-60EA - Each33261-048da509f72-2826-4d60-a71f-614239ac1d3412015-10-02
33261-048-90EA - Each33261-0482c20f6dd-d806-46d7-81eb-01404d38daf712015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-048GABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 12 package rows20120927_cd2d3b9d-09cc-4342-9888-9b2e792a51ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310430gabapentin 100 MG Oral CapsulePSNcd2d3b9d-09cc-4342-9888-9b2e792a51ee3
310431gabapentin 300 MG Oral CapsulePSNcd2d3b9d-09cc-4342-9888-9b2e792a51ee3
310432gabapentin 400 MG Oral CapsulePSNcd2d3b9d-09cc-4342-9888-9b2e792a51ee3
310430gabapentin 100 MG Oral CapsuleSCDcd2d3b9d-09cc-4342-9888-9b2e792a51ee3
310431gabapentin 300 MG Oral CapsuleSCDcd2d3b9d-09cc-4342-9888-9b2e792a51ee3
310432gabapentin 400 MG Oral CapsuleSCDcd2d3b9d-09cc-4342-9888-9b2e792a51ee3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-048-0033261004800100 in 1 BOTTLEHistorical
33261-048-0233261004802120 in 1 BOTTLEHistorical
33261-048-103326100481010 in 1 BOTTLEHistorical
33261-048-203326100482020 in 1 BOTTLEHistorical
33261-048-213326100482121 in 1 BOTTLEHistorical
33261-048-303326100483030 in 1 BOTTLEHistorical
33261-048-453326100484545 in 1 BOTTLEHistorical
33261-048-603326100486060 in 1 BOTTLEHistorical
33261-048-813326100488181 in 1 BOTTLEHistorical
33261-048-903326100489090 in 1 BOTTLEHistorical
33261-048-9733261004897126 in 1 BOTTLEHistorical
33261-048-9933261004899180 in 1 CAPSULEHistorical