Application 200651

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINTABLET;ORAL600MGNoNo
002GABAPENTINGABAPENTINTABLET;ORAL800MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A200651-001GABAPENTINGABAPENTIN600MGTABLET / ORALAB12011-10-06
A200651-002GABAPENTINGABAPENTIN800MGTABLET / ORALAB12011-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200651-001AB1
A200651-002AB1

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 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200651-001GABAPENTIN600MGTABLET / ORALAB12011-10-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200651-002GABAPENTIN800MGTABLET / ORALAB12011-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200651-001GABAPENTIN600MGTABLET / ORALAB2011-10-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200651-002GABAPENTIN800MGTABLET / ORALAB2011-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200651-001GABAPENTIN600MGTABLET / ORALAB2011-10-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200651-002GABAPENTIN800MGTABLET / ORALAB2011-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200651-001GABAPENTIN600MGTABLET / ORALAB2011-10-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200651-002GABAPENTIN800MGTABLET / ORALAB2011-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200651-001GABAPENTIN600MGTABLET / ORALAB2011-10-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200651-002GABAPENTIN800MGTABLET / ORALAB2011-10-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200651-001GABAPENTIN600MGTABLET / ORALAB2011-10-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200651-002GABAPENTIN800MGTABLET / ORALAB2011-10-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200651-001GABAPENTIN600MGTABLET / ORALAB2011-10-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A200651-002GABAPENTIN800MGTABLET / ORALAB2011-10-06782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200651-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200651-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200651-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200651-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200651-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200651-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200651-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200651-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200651-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200651-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200651-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200651-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200651-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200651-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200651-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200651-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200651-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200651-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200651-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A200651-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200651-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200651-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200651-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200651-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200651-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200651-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200651-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200651-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200651-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200651-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200651-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200651-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200651-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200651-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200651-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200651-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200651-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200651-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200651-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200651-002AB1782e0a99824c…

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINREMEDYREPACK INC.5a78ab50-993d-4857-be10-be665e02b3532026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 70518-2356
GabapentinGABAPENTINREMEDYREPACK INC.429a1bb5-babf-4f36-8264-46d71164f1c02026-07-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 70518-2323
GabapentinGABAPENTINREMEDYREPACK INC.7ddc7d92-9076-41cf-97ed-d9f9edc802982026-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 70518-2616
GabapentinGABAPENTINCardinal Health 107, LLCb2da7d96-73ad-4f44-8784-160a384a09612026-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 55154-3366
ndc (product): 55154-3357
GabapentinGABAPENTINMajor Pharmaceuticals152adf1d-ec0c-4561-bf80-e4c7da1587232026-05-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 0904-6823
ndc (product): 0904-7108
GabapentinGABAPENTINA-S Medication Solutions0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d2026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINA-S Medication Solutions2343e3a1-82d0-4c70-a086-a01a0ce81ef32026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINBryant Ranch Prepackd9d78138-e1e9-4107-9099-4910cb1422d82025-10-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINBryant Ranch Prepackbe9a572d-e98a-41c1-83c5-859d9176dd1c2025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINBryant Ranch Prepack8f982b95-4e84-4e0c-a543-747bc3dd75312025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINBryant Ranch Prepackd0510d04-460c-47d1-be72-0ee32c4ac6402025-09-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINNorthStar Rx LLC9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a2025-07-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 16714-332
ndc (product): 16714-330
GabapentinGABAPENTINQUALLENT PHARMACEUTICALS HEALTH LLC472bb279-bb4e-4246-b2a3-172483ba356b2025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
GabapentinGABAPENTINAurobindo Pharma Limited25cf6c40-a239-4dd0-9cad-28da84d285db2025-05-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 65862-523
ndc (product): 65862-524
GABAPENTINGABAPENTINDIRECT RXa5b47f89-ed35-31de-e053-2a95a90a55542025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 72189-092
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafa28969-91c8-83fd-e053-2a95a90a656b2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 80425-0036
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCb37b1dcc-c7e9-8845-e053-2995a90a089e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 80425-0097
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc898711b-9a65-1816-e053-2995a90a855e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 80425-0158
GabapentinGABAPENTINProficient Rx LPc79d94ec-117d-4fb6-845d-1954e3472bb02021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200651
application number: ANDA200651
ndc (product): 63187-148

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 81 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6823GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6823GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6823GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-6823GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-7108GabapentinGabapentinMajor PharmaceuticalsANDACurrent
0904-7108GabapentinGabapentinMajor PharmaceuticalsANDACurrent
16714-330GabapentinGabapentinNorthStar Rx LLCANDACurrent
16714-330GabapentinGabapentinNorthStar Rx LLCANDACurrent
16714-330GabapentinGabapentinNorthStar Rx LLCANDACurrent
16714-330GabapentinGabapentinNorthStar Rx LLCANDACurrent
16714-330GabapentinGabapentinNorthStar Rx LLCANDACurrent
16714-330GabapentinGabapentinNorthStar Rx LLCANDACurrent
16714-332GabapentinGabapentinNorthStar Rx LLCANDACurrent
16714-332GabapentinGabapentinNorthStar Rx LLCANDACurrent
16714-332GabapentinGabapentinNorthStar Rx LLCANDACurrent
16714-332GabapentinGabapentinNorthStar Rx LLCANDACurrent
16714-332GabapentinGabapentinNorthStar Rx LLCANDACurrent
16714-332GabapentinGabapentinNorthStar Rx LLCANDACurrent
33261-051GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
33261-116GabapentinGabapentinAidarex Pharmaceuticals LLCANDACurrent
42292-024GabapentinGabapentinMylan Institutional Inc.ANDACurrent
42292-025GabapentinGabapentinMylan Institutional Inc.ANDACurrent
42292-025GabapentinGabapentinMylan Institutional Inc.ANDACurrent
55154-3357GabapentinGabapentinCardinal HealthANDACurrent
55154-3357GabapentinGabapentinCardinal HealthANDACurrent
55154-3366GabapentinGabapentinCardinal HealthANDACurrent
63187-148GabapentinGabapentinProficient Rx LPANDACurrent
63187-148GabapentinGabapentinProficient Rx LPANDACurrent
63629-6339GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-6339GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-6442GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-6442GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-6442GabapentinGabapentinBryant Ranch PrepackANDACurrent
63629-6442GabapentinGabapentinBryant Ranch PrepackANDACurrent
65862-523GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-523GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-523GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-523GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-523GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-523GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-523GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-523GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-523GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-524GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-524GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-524GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-524GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-524GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-524GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-524GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-524GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
65862-524GabapentinGabapentinAurobindo Pharma LimitedANDACurrent
68788-9923GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2323GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2323GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2323GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2323GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2356GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2356GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2356GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2356GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2356GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2616GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2616GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2616GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2616GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2616GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2616GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70934-636GabapentinGabapentinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
72189-092GABAPENTINGABAPENTINDIRECT RXANDACurrent
80425-0036NeurontinGabapentin 800mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0036NeurontinGabapentin 800mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0036GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0036GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0097NeurontinGabapentin 600mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0097GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0097GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0097GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0158NeurontinGabapentin 800mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0158GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent