GABAPENTIN

Product NDC
68071-2353
11-digit product format
680712353
Labeler code
68071
Product ID
68071-2353_bc953485-25ef-0fe0-e053-2a95a90a2632
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GABAPENTIN
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA205101
Marketing category
ANDA
Marketing start
2016-11-20
Marketing end
2022-09-23
Substance
GABAPENTIN
Active strength
800 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2353DDiscontinued by firm2026-08-17
excluded packagepackage68071-235368071-2353-9DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2353-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2353-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2353-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2353-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2353-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2353-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2353-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2353-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2353-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-2353-9ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-2353-9367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-2353-9557ba5c1ecfa…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
A205101-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12016-02-04
A205101-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12016-02-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205101-001AB1
A205101-002AB1

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 06:07:402026-07A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205101-001GABAPENTIN600MGTABLET / ORALAB12016-02-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205101-002GABAPENTIN800MGTABLET / ORALAB12016-02-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205101-001GABAPENTIN600MGTABLET / ORALAB2016-02-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205101-002GABAPENTIN800MGTABLET / ORALAB2016-02-04bb7c543d1eb4…

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 06:07:402026-07A205101-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A205101-002AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205101-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205101-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205101-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205101-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205101-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205101-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205101-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205101-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205101-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205101-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205101-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205101-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205101-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205101-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205101-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205101-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205101-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205101-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205101-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A205101-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205101-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205101-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205101-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205101-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205101-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205101-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205101-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205101-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205101-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205101-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205101-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205101-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205101-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205101-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205101-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205101-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205101-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205101-002AB1bb7c543d1eb4…

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 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.9b175f8d-7667-4bfe-8bb5-fd7441eed4562026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINHAWAII REPACK, INC.f6ff265b-569b-4f5c-8fdb-00b7ad4aac7c2026-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyba4d863d-be38-8cf5-e053-2995a90a69fb2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyc85ae572-9893-629e-e053-2995a90a23fc2026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINBryant Ranch Prepackce0f0d7f-da6d-47da-a4ed-fb8f729024122026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINBryant Ranch Prepackabb56036-88df-4720-ba78-5299716715452026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINBryant Ranch Prepacka75c9157-a1fc-44cc-89f8-c5a3742fb9ed2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINBryant Ranch Prepackd1aa4690-57b5-4a3e-ac12-85f777dbd05e2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINBryant Ranch Prepack75caca13-1432-4c0d-8d45-f029b0b2d4172026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINBryant Ranch Prepack56378630-e7a7-4981-8212-8ea703a433d82026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINRadha Pharmaceuticals, Inc.1045db4e-4c76-4a0d-bf12-019bd96a8f592026-03-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINScieGen Pharmaceuticals, Inc.5ab9c18b-9568-4dcb-90b0-252aef8f8dc22026-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.5d3f27bf-3486-40fa-a4d3-5f0b2c6c01512025-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.561f53d5-5301-42b3-b372-f3d49d642a2e2025-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINCoupler LLC3133fc78-dd7a-880c-e063-6394a90a89e12025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINDirectrxd5c9dd2c-b8ee-1406-e053-2995a90a02872025-01-21Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GABAPENTINGABAPENTINDIRECT RXa7e45e3f-e382-32ba-e053-2a95a90a25372025-01-17Exact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINCreekwood Pharmaceuticals LLC266ef369-0a56-f225-e063-6294a90a495e2024-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a9c99dfa-f54d-9207-e053-2995a90ad43b2024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a9f0852e-0c58-ba22-e053-2995a90adfa02024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205101
application number: ANDA205101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2353-96807123530990 TABLET in 1 BOTTLE (68071-2353-9) 90 tablet2016-11-202022-09-23NoNoCurrent