FDA.reportPublic FDA data

NDC 63629-7306-01 - Gabapentin

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63629-7306
Requested NDC
63629-7306-01
Package NDCs from labels
63629-7306-8, 63629-7306-1, 63629-7306-2, 63629-7306-3, 63629-7306-4, 63629-7306-5, 63629-7306-6, 63629-7306-7, 63629-7306-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-10-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gabapentin - Bryant Ranch PrepackBryant Ranch Prepack2024-10-29HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-7306-12020-02-25These 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
63629-7306-22020-02-25These 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
63629-7306-32020-02-25These 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
63629-7306-42020-02-25These 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
63629-7306-52020-02-25These 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
63629-7306-62020-02-25These 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
63629-7306-12020-01-31These 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
63629-7306-22020-01-31These 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
63629-7306-32020-01-31These 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
63629-7306-42020-01-31These 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
63629-7306-52020-01-31These 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
63629-7306-62020-01-31These 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
63629-7306-1Gabapentin90 in 1 BOTTLECAPSULE9018
63629-7306-2Gabapentin28 in 1 BOTTLECAPSULE2818
63629-7306-3Gabapentin58 in 1 BOTTLECAPSULE5818
63629-7306-4Gabapentin30 in 1 BOTTLECAPSULE3018
63629-7306-5Gabapentin60 in 1 BOTTLECAPSULE6018
63629-7306-6Gabapentin120 in 1 BOTTLECAPSULE12018
63629-7306-7Gabapentin180 in 1 BOTTLECAPSULE18018
63629-7306-8Gabapentin40 in 1 BOTTLECAPSULE4018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7306GABAPENTIN CAPSULE [BRYANT RANCH PREPACK]18Current NDC, Legacy NDC, 8 package rows20241109_506bf880-9564-404c-951a-703797ffdad8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7306-1EA - Each63629-7306f5bd29ca-243c-4597-b659-f6a28ed6b6f912017-11-06
63629-7306-2EA - Each63629-73061561a545-c1aa-4a7d-be56-94e7255d28e512017-11-06
63629-7306-3EA - Each63629-7306d88b61f7-4ece-4701-a937-3997152df80412017-11-06
63629-7306-4EA - Each63629-730618d5dc4e-5eab-4e9d-ae96-f5810f1b359e12017-11-06
63629-7306-5EA - Each63629-73068512f5cd-ed39-4c18-8d93-71c674eed2de12017-11-06
63629-7306-6EA - Each63629-73062d7814ee-6885-40e6-a97f-989726e37f7112018-12-13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINCardinal Health 107, LLCb2da7d96-73ad-4f44-8784-160a384a09612026-06-03Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyf93eaa4f-cc1a-10ab-e053-6394a90a5ffc2026-06-02Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
GabapentinGABAPENTINDirect_Rxf8998c1c-c359-6f01-e053-6294a90aebf42026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X
gabapentinGABAPENTINProficient Rx LPc7674ea5-276b-4bb3-821b-4ac05c9e64e62026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 310432
unii: 6CW7F3G59X
GabapentinGABAPENTINAmneal Pharmaceuticals LLC507bf6d0-e7a2-413d-9848-cd2445a1411d2026-05-30Warnings, Adverse reactionsExact identifier
application number: ANDA078428
ndc (product): 65162-102
rxcui: 310430
rxcui: 310432
rxcui: 310431
spl id: 385f01e9-5b50-41d8-a2d5-748f5f84c027
spl set id: 507bf6d0-e7a2-413d-9848-cd2445a1411d
unii: 6CW7F3G59X
GabapentinGABAPENTINLaurus Labs Limited07aa1bcc-df05-44fa-92d4-63894e0e6cd62026-05-28Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINA-S Medication Solutions03031adf-d36b-45ec-944e-dfce5a5de91a2026-05-28Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GABAPENTINGABAPENTINPangea Pharmaceuticals, LLC5eff7ad8-0d31-4372-82a2-ac9f549d87962026-05-22Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINBryant Ranch Prepack397fd6d3-317b-4b61-a52b-3a09ca1d88a42026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GABAPENTINGABAPENTINBryant Ranch Prepack13640281-26b4-402e-8f69-7c81cd6e03762026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINAmici Pharma, Inc.1ea83c18-7107-41f4-8305-62725c1c45c82026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINCardinal Health 107, LLCd4f21e97-5e55-44c9-9b31-5f79ac2eb5122026-05-18Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310431
unii: 6CW7F3G59X
NeurontinGABAPENTINViatris Specialty LLC97935fd9-1d4a-43b6-a5d9-de994591187b2026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GabapentinGABAPENTINCardinal Health 107, LLCeeb19a5a-b31d-4df8-9546-0b2b5eb5db072026-05-07Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINMajor Pharmaceuticals152adf1d-ec0c-4561-bf80-e4c7da1587232026-05-04Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINMajor Pharmaceuticals999f3685-2eac-467e-bed2-1d0c36aaf0ed2026-05-04Warnings, Adverse reactionsExact identifier
rxcui: 310430
rxcui: 310432
rxcui: 310431
unii: 6CW7F3G59X
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee2026-05-04Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.35da078b-0da0-4757-a6c4-a9144c37e8e12026-05-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.38119f2e-33b3-4c3c-99b7-9335d8d280d42026-05-01Warnings, Adverse reactionsExact identifier
unii: 6CW7F3G59X
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyb8b7e045-a7fe-8539-e053-2a95a90a40f82026-05-01Warnings, Adverse reactionsExact identifier
rxcui: 310430
unii: 6CW7F3G59X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.