Gabapentin

Product NDC
63629-3063
Requested package NDC
63629-3063-8
11-digit product format
636293063
Labeler code
63629
Product ID
63629-3063_f8194665-0d50-4ebd-8c82-5df9c2c8b3f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077662
Marketing category
ANDA
Marketing start
2006-04-01
Substance
GABAPENTIN
Active strength
600 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077662-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12006-08-18
A077662-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12006-08-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077662-001AB1
A077662-002AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18caaa826d4ba7…
2026-08-18 06:07:402026-07A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077662-001GABAPENTIN600MGTABLET / ORALAB12006-08-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077662-002GABAPENTIN800MGTABLET / ORALAB12006-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-1874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077662-001GABAPENTIN600MGTABLET / ORALAB2006-08-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077662-002GABAPENTIN800MGTABLET / ORALAB2006-08-18bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077662-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A077662-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077662-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077662-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077662-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077662-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077662-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077662-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077662-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077662-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077662-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077662-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077662-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077662-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A077662-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077662-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077662-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077662-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077662-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077662-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077662-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077662-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077662-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077662-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077662-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077662-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077662-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077662-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077662-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN600 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6CW7F3G59XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310433Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
632cb507-5675-2392-0460-b09c0dd14650Available on FDA.report

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, Related label table
NDCEffectiveRelated label
63629-3063-02020-02-25These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-12020-02-25These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-22020-02-25These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-32020-02-25These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-42020-02-25These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-52020-02-25These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-62020-02-25These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-72020-02-25These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-82020-02-25These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-92020-02-25These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-02020-01-31These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-12020-01-31These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-22020-01-31These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-32020-01-31These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-42020-01-31These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-52020-01-31These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-62020-01-31These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-72020-01-31These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-82020-01-31These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993
63629-3063-92020-01-31These highlights do not include all the information needed to use GABAPENTIN TABLETS safely and effectively. See full prescribing information for GABAPENTIN TABLETS. GABAPENTIN tablets, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-3063-0Gabapentin45 in 1 BOTTLETABLET4519
63629-3063-1Gabapentin30 in 1 BOTTLETABLET3019
63629-3063-2Gabapentin60 in 1 BOTTLETABLET6019
63629-3063-3Gabapentin180 in 1 BOTTLETABLET18019
63629-3063-4Gabapentin90 in 1 BOTTLETABLET9019
63629-3063-5Gabapentin100 in 1 BOTTLETABLET10019
63629-3063-6Gabapentin120 in 1 BOTTLETABLET12019
63629-3063-7Gabapentin56 in 1 BOTTLETABLET5619
63629-3063-8Gabapentin84 in 1 BOTTLETABLET8419
63629-3063-9Gabapentin112 in 1 BOTTLETABLET11219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3063-1EA - Each63629-30632d0d8707-c28b-4f6e-9e3b-bd173fc2db4612012-07-24
63629-3063-2EA - Each63629-306363161452-fd11-48fa-99dc-11235436719312012-07-24
63629-3063-3EA - Each63629-3063c5760a30-63f5-4844-9b79-5c4e788a6f2212012-07-24
63629-3063-4EA - Each63629-30639a9b270f-6955-4176-aef0-b9ad40374acc12012-07-24
63629-3063-5EA - Each63629-306393e2d1dd-625e-4c7b-876b-9b7068c9f13a12012-07-24
63629-3063-6EA - Each63629-3063fea6bc8f-9afe-4318-b629-18953c874fc912012-07-24
63629-3063-7EA - Each63629-3063699dc091-3149-4b20-910e-b423ae5ab99412015-02-02
63629-3063-8EA - Each63629-306383c1ac21-70e6-4aaa-b747-40762c001d3512015-02-02
63629-3063-9EA - Each63629-3063e9c81794-8880-4697-8a3a-a577fc3bc4b412015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GABAPENTINACTIVE INGREDIENT6CW7F3G59XGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
GABAPENTINACTIVE MOIETY6CW7F3G59XGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GABAPENTIN TABLET [BRYANT RANCH PREPACK]3
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2GABAPENTIN TABLET [BRYANT RANCH PREPACK]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGABAPENTIN TABLET [BRYANT RANCH PREPACK]3
WATERINACTIVE INGREDIENT059QF0KO0RGABAPENTIN TABLET [BRYANT RANCH PREPACK]3

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 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINCoupler LLC583ab038-7b6e-96f8-e063-6294a90adf472026-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINUnit Dose Solutions, Inc.54edd6f3-06c7-a0c7-e063-6394a90a8b4f2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack4cb26d6e-7963-4fe5-903e-ab51805450662026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBluePoint Laboratories3368bf70-d466-4765-b2b7-7fe967a8c2b72026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack632cb507-5675-2392-0460-b09c0dd146502026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
ndc (package): 63629-3063-8
ndc (product): 63629-3063
ndc11 (package): 63629306308
GabapentinGABAPENTINGlenmark Pharmaceuticals Inc., USA3865a6e3-112c-490c-82ac-35401336b16e2025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack137b2b9a-9d42-48d0-913f-5dc146fb689a2025-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINBryant Ranch Prepack2278ce1b-1c19-4ad2-89c6-4530f7b78ea72025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.7c3b232a-3e9f-4249-9e5a-295482ee288a2025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662
GabapentinGABAPENTINProficient Rx LPc78f528f-9192-4037-bfb9-ff5718ed26c52019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077662
application number: ANDA077662

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310433gabapentin 600 MG Oral TabletPSN632cb507-5675-2392-0460-b09c0dd1465019
310433gabapentin 600 MG Oral TabletSCD632cb507-5675-2392-0460-b09c0dd1465019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3063-86362930630884 TABLET in 1 BOTTLE (63629-3063-8) 84 tablet2026-04-070000-00-00NoNoCurrent