FDA.reportPublic FDA data

GABAPENTIN

Product NDC
68071-1212
11-digit product format
680711212
Labeler code
68071
Product ID
68071-1212_bafe6c51-96ec-7414-e053-2995a90a8488
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA090705
Marketing category
ANDA
Marketing start
2016-06-29
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
2022-12-31
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1212-12023-01-30C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-22023-01-30C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-32023-01-30C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-42023-01-30C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-52023-01-30C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-62023-01-30C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-72023-01-30C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-82023-01-30C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-92023-01-30C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-12021-02-10C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-22021-02-10C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-32021-02-10C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-42021-02-10C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-52021-02-10C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-62021-02-10C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-72021-02-10C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-82021-02-10C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-92021-02-10C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-12021-01-29C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-22021-01-29C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-32021-01-29C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-42021-01-29C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-52021-01-29C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-62021-01-29C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-72021-01-29C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-82021-01-29C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993
68071-1212-92021-01-29C16284748780-1ba0f9c33-2c70-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use, Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1212-1GABAPENTIN120 in 1 BOTTLECAPSULE1202
68071-1212-2GABAPENTIN270 in 1 BOTTLECAPSULE2702
68071-1212-3GABAPENTIN30 in 1 BOTTLECAPSULE302
68071-1212-4GABAPENTIN84 in 1 BOTTLECAPSULE842
68071-1212-5GABAPENTIN14 in 1 BOTTLECAPSULE142
68071-1212-6GABAPENTIN60 in 1 BOTTLECAPSULE602
68071-1212-7GABAPENTIN7 in 1 BOTTLECAPSULE72
68071-1212-8GABAPENTIN180 in 1 BOTTLECAPSULE1802
68071-1212-9GABAPENTIN90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1212GABAPENTIN CAPSULE [NUCARE PHARMACEUTICALS, INC.]2Legacy NDC, 9 package rows20210211_4b82425c-dffc-61db-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN4b82425c-dffc-61db-e054-00144ff88e882
310431gabapentin 300 MG Oral CapsuleSCD4b82425c-dffc-61db-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1212-168071121201120 CAPSULE in 1 BOTTLE (68071-1212-1) 120 capsule2017-03-240000-00-00NoNoCurrent
68071-1212-268071121202270 CAPSULE in 1 BOTTLE (68071-1212-2) 270 capsule2017-03-240000-00-00NoNoCurrent
68071-1212-36807112120330 CAPSULE in 1 BOTTLE (68071-1212-3) 30 capsule2017-03-240000-00-00NoNoCurrent
68071-1212-46807112120484 CAPSULE in 1 BOTTLE (68071-1212-4) 84 capsule2017-03-240000-00-00NoNoCurrent
68071-1212-56807112120514 CAPSULE in 1 BOTTLE (68071-1212-5) 14 capsule2017-03-240000-00-00NoNoCurrent
68071-1212-66807112120660 CAPSULE in 1 BOTTLE (68071-1212-6) 60 capsule2017-03-240000-00-00NoNoCurrent
68071-1212-7680711212077 CAPSULE in 1 BOTTLE (68071-1212-7) 7 capsule2017-03-240000-00-00NoNoCurrent
68071-1212-868071121208180 CAPSULE in 1 BOTTLE (68071-1212-8) 180 capsule2017-03-240000-00-00NoNoCurrent
68071-1212-96807112120990 CAPSULE in 1 BOTTLE (68071-1212-9) 90 capsule2017-03-240000-00-00NoNoCurrent