FDA.reportPublic FDA data

Gabapentin

Product NDC
33261-049
11-digit product format
332610049
Labeler code
33261
Product ID
33261-049_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
300 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
33261-049-002020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-049-022020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-049-102020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-049-202020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-049-212020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-049-302020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-049-422020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-049-452020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-049-602020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-049-812020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-049-902020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-049-972020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP
33261-049-992020-01-31C16284748780-19d75b9d0-87f7-f424-e053-dadaa90a57ceGabapentin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-049-00Gabapentin100 in 1 BOTTLECAPSULE1003
33261-049-02Gabapentin120 in 1 BOTTLECAPSULE1203
33261-049-10Gabapentin10 in 1 BOTTLECAPSULE103
33261-049-20Gabapentin20 in 1 BOTTLECAPSULE203
33261-049-21Gabapentin21 in 1 BOTTLECAPSULE213
33261-049-30Gabapentin30 in 1 BOTTLECAPSULE303
33261-049-42Gabapentin42 in 1 BOTTLECAPSULE423
33261-049-45Gabapentin45 in 1 BOTTLECAPSULE453
33261-049-60Gabapentin60 in 1 BOTTLECAPSULE603
33261-049-81Gabapentin81 in 1 BOTTLECAPSULE813
33261-049-90Gabapentin90 in 1 BOTTLECAPSULE903
33261-049-97Gabapentin126 in 1 BOTTLECAPSULE1263
33261-049-99Gabapentin180 in 1 BOTTLECAPSULE1803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-049-00EA - Each33261-04900a99d2f-e0ce-4202-9544-49f4a226c48712015-10-02
33261-049-02EA - Each33261-04910699a88-a613-413a-9925-b7a6c3e8c43b12015-10-02
33261-049-10EA - Each33261-04916c4d288-158c-4380-818e-c53ad8409c2a12015-10-02
33261-049-20EA - Each33261-049ec8758ba-648c-427e-bae1-c29ef029d39012015-10-02
33261-049-21EA - Each33261-049cf641e31-66a7-4411-9f7e-678dcc7c921612015-10-02
33261-049-30EA - Each33261-04986b126d7-a5ec-4069-aded-495109c16bca12015-10-02
33261-049-42EA - Each33261-049c85555cc-ffd2-4c26-b69e-af8a6ecfcfba12015-10-02
33261-049-45EA - Each33261-0490cfdbc62-1c16-4601-8eb3-5c644af54dd412015-10-02
33261-049-60EA - Each33261-049536859dc-67d8-4bfe-8b6f-dfc1e0034f4c12015-10-02
33261-049-81EA - Each33261-0498699660f-a71c-47c3-b3e1-03c7af02b8ca12015-10-02
33261-049-90EA - Each33261-049859c4fa0-1373-4f77-b169-f1427d16b5a312015-10-02
33261-049-99EA - Each33261-049caf1937a-5c59-44f8-924a-9ac37577b0c412015-10-02

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
33261-049GABAPENTIN 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
33261-049-0033261004900100 in 1 BOTTLEHistorical
33261-049-0233261004902120 in 1 BOTTLEHistorical
33261-049-103326100491010 in 1 BOTTLEHistorical
33261-049-203326100492020 in 1 BOTTLEHistorical
33261-049-213326100492121 in 1 BOTTLEHistorical
33261-049-303326100493030 in 1 BOTTLEHistorical
33261-049-423326100494242 in 1 BOTTLEHistorical
33261-049-453326100494545 in 1 BOTTLEHistorical
33261-049-603326100496060 in 1 BOTTLEHistorical
33261-049-813326100498181 in 1 BOTTLEHistorical
33261-049-903326100499090 in 1 BOTTLEHistorical
33261-049-9733261004997126 in 1 BOTTLEHistorical
33261-049-9933261004999180 in 1 BOTTLEHistorical