FDA.reportPublic FDA data

Gabapentin

Product NDC
33261-050
11-digit product format
332610050
Labeler code
33261
Product ID
33261-050_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
400 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
33261-050-002020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-050-022020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-050-102020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-050-202020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-050-212020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-050-302020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-050-422020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-050-452020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-050-602020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-050-812020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-050-902020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-050-972020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-050-992020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-050-00Gabapentin100 in 1 BOTTLECAPSULE1003
33261-050-02Gabapentin120 in 1 BOTTLECAPSULE1203
33261-050-10Gabapentin10 in 1 BOTTLECAPSULE103
33261-050-20Gabapentin20 in 1 BOTTLECAPSULE203
33261-050-21Gabapentin21 in 1 BOTTLECAPSULE213
33261-050-30Gabapentin30 in 1 BOTTLECAPSULE303
33261-050-42Gabapentin42 in 1 BOTTLECAPSULE423
33261-050-45Gabapentin45 in 1 BOTTLECAPSULE453
33261-050-60Gabapentin60 in 1 BOTTLECAPSULE603
33261-050-81Gabapentin81 in 1 BOTTLECAPSULE813
33261-050-90Gabapentin90 in 1 BOTTLECAPSULE903
33261-050-97Gabapentin126 in 1 BOTTLECAPSULE1263
33261-050-99Gabapentin180 in 1 BOTTLECAPSULE1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-050-02EA - Each33261-0505c99ef90-ba2e-4fe3-83ff-7123ab50baae12013-02-13
33261-050-30EA - Each33261-0506aade406-7700-4683-9d75-fd6247608cac12013-02-13
33261-050-60EA - Each33261-050ebf0373c-3d5d-4813-a15b-b05e41245b5012013-02-13
33261-050-90EA - Each33261-050d0ff43c6-a01e-4bef-b560-bd12b9516af012013-02-13

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
33261-050GABAPENTIN CAPSULE [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 13 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
33261-050-0033261005000100 in 1 BOTTLEHistorical
33261-050-0233261005002120 in 1 BOTTLEHistorical
33261-050-103326100501010 in 1 BOTTLEHistorical
33261-050-203326100502020 in 1 BOTTLEHistorical
33261-050-213326100502121 in 1 BOTTLEHistorical
33261-050-303326100503030 in 1 BOTTLEHistorical
33261-050-423326100504242 in 1 BOTTLEHistorical
33261-050-453326100504545 in 1 BOTTLEHistorical
33261-050-603326100506060 in 1 BOTTLEHistorical
33261-050-813326100508181 in 1 BOTTLEHistorical
33261-050-903326100509090 in 1 BOTTLEHistorical
33261-050-9733261005097126 in 1 BOTTLEHistorical
33261-050-9933261005099180 in 1 BOTTLEHistorical