FDA.reportPublic FDA data

Gabapentin

Product NDC
33261-116
11-digit product format
332610116
Labeler code
33261
Product ID
33261-116_0756b645-0741-4473-b777-7ee472358140
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA200651
Marketing category
ANDA
Marketing start
2011-10-06
Marketing end
0000-00-00
Substance
GABAPENTIN
Active strength
800 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-116-002020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP
33261-116-022020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP
33261-116-102020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP
33261-116-202020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP
33261-116-212020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP
33261-116-302020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP
33261-116-422020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP
33261-116-452020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP
33261-116-602020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP
33261-116-812020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP
33261-116-902020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP
33261-116-972020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP
33261-116-992020-01-31C16284748780-19d75b9d0-03ac-f424-e053-dadaa90a57ceGabapentin Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-116-00Gabapentin100 in 1 BOTTLETABLET, FILM COATED1003
33261-116-02Gabapentin120 in 1 BOTTLETABLET, FILM COATED1203
33261-116-10Gabapentin10 in 1 BOTTLETABLET, FILM COATED103
33261-116-20Gabapentin20 in 1 BOTTLETABLET, FILM COATED203
33261-116-21Gabapentin21 in 1 BOTTLETABLET, FILM COATED213
33261-116-30Gabapentin30 in 1 BOTTLETABLET, FILM COATED303
33261-116-42Gabapentin42 in 1 BOTTLETABLET, FILM COATED423
33261-116-45Gabapentin45 in 1 BOTTLETABLET, FILM COATED453
33261-116-60Gabapentin60 in 1 BOTTLETABLET, FILM COATED603
33261-116-81Gabapentin81 in 1 BOTTLETABLET, FILM COATED813
33261-116-90Gabapentin90 in 1 BOTTLETABLET, FILM COATED903
33261-116-97Gabapentin126 in 1 BOTTLETABLET, FILM COATED1263
33261-116-99Gabapentin180 in 1 BOTTLETABLET, FILM COATED1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-116-02EA - Each33261-1165b288574-c527-4186-93b3-be571d68175612015-10-02
33261-116-30EA - Each33261-116445bcca0-b30f-4ca7-a226-9f6b9053d6eb12015-10-02
33261-116-60EA - Each33261-1162d330cc2-30a9-463c-9007-09cf0a6e970212015-10-02
33261-116-90EA - Each33261-1166abf8408-87eb-415a-8ba7-dc7e88551d7812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]3
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-116GABAPENTIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 13 package rows20120927_41f1e929-7c1f-4b3e-b142-4b7533300ee2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN41f1e929-7c1f-4b3e-b142-4b7533300ee23
310434gabapentin 800 MG Oral TabletPSN41f1e929-7c1f-4b3e-b142-4b7533300ee23
310433gabapentin 600 MG Oral TabletSCD41f1e929-7c1f-4b3e-b142-4b7533300ee23
310434gabapentin 800 MG Oral TabletSCD41f1e929-7c1f-4b3e-b142-4b7533300ee23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-116-0033261011600100 in 1 BOTTLEHistorical
33261-116-0233261011602120 in 1 BOTTLEHistorical
33261-116-103326101161010 in 1 BOTTLEHistorical
33261-116-203326101162020 in 1 BOTTLEHistorical
33261-116-213326101162121 in 1 BOTTLEHistorical
33261-116-303326101163030 in 1 BOTTLEHistorical
33261-116-423326101164242 in 1 BOTTLEHistorical
33261-116-453326101164545 in 1 BOTTLEHistorical
33261-116-603326101166060 in 1 BOTTLEHistorical
33261-116-813326101168181 in 1 BOTTLEHistorical
33261-116-903326101169090 in 1 BOTTLEHistorical
33261-116-9733261011697126 in 1 BOTTLEHistorical
33261-116-9933261011699180 in 1 BOTTLEHistorical