Application 203244

Type
ANDA
Sponsor
ACI HEALTHCARE LTD

Application Products#

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

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
A203244-001GABAPENTINGABAPENTIN800MGTABLET / ORALAB12013-07-12
A203244-002GABAPENTINGABAPENTIN600MGTABLET / ORALAB12013-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203244-001AB1
A203244-002AB1

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 UTC2026-02A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203244-001GABAPENTIN800MGTABLET / ORALAB12013-07-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203244-002GABAPENTIN600MGTABLET / ORALAB12013-07-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203244-001GABAPENTIN800MGTABLET / ORALAB2013-07-12782e0a99824c…
2021-12-28 21:50 UTC2021-12A203244-002GABAPENTIN600MGTABLET / ORALAB2013-07-12782e0a99824c…

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 UTC2026-02A203244-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203244-002AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203244-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203244-002AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203244-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203244-002AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203244-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203244-002AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203244-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203244-002AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203244-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203244-002AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203244-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203244-002AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203244-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203244-002AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203244-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203244-002AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203244-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203244-002AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203244-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203244-002AB1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203244-001AB11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203244-002AB11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203244-001AB111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203244-002AB111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203244-001AB118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203244-002AB118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203244-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203244-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203244-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203244-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203244-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203244-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203244-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203244-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203244-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203244-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203244-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203244-002AB1782e0a99824c…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINREMEDYREPACK INC.07c8bb17-9bd4-4fab-994d-0412205b53b42026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
ndc (product): 70518-2098
GabapentinGABAPENTINBryant Ranch Prepackb6db5ce9-bd4b-420d-88a7-df9d46144c812026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINStrides Pharma Science Limitedbec31452-b52b-4698-ba4c-0b614780ee842025-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy7d3fc163-25f0-2c61-e053-2991aa0a76e92025-05-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
ndc (product): 60760-066
GABAPENTINGABAPENTINDIRECT RXa7e45e3f-e382-32ba-e053-2a95a90a25372025-01-17Exact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepack6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb2024-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepack47f2a06f-4eac-4dca-aa2a-a36dd4daaea02024-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
ndc (product): 71335-1007
GabapentinGABAPENTINBryant Ranch Prepackb4954172-5439-48fd-8348-8a2e0d2fee622024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepackc9944562-563a-423d-972c-f0313375d2342024-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepack56967a93-b3c0-4043-9241-585fc64e26242023-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINBryant Ranch Prepack0eb27e64-1488-4083-82c7-cebb8c0605de2023-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINACI Healthcare USA, Inc.d7646d5e-ca25-4ec5-9e4b-931edcb15a0e2023-12-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
ndc (product): 71093-112
ndc (product): 71093-111
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC39149f0e-30ed-4671-8be7-2a484f65d63b2020-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINProficient Rx LP8b2f38ef-0a0c-45cc-88ca-cc086bf806412020-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
ndc (product): 71205-457
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCba2a8352-5776-4edb-914e-ce1d18ccda322020-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
GabapentinGABAPENTINProficient Rx LPc09c66fd-cb31-41dd-b00b-acc58bd809f72020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203244
application number: ANDA203244
ndc (product): 71205-160

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 103 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43547-332GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-332GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-333GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
43547-333GabapentinGABAPENTINSolco Healthcare U.S., LLCANDACurrent
45865-122GabapentinGABAPENTINMedsource PharmaceuticalsANDACurrent
45865-995GabapentinGABAPENTINmedsource pharmaceuticalsANDACurrent
55700-278GabapentinGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-389GabapentinGABAPENTINLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-780GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-780GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-780GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-780GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
55700-815GabapentinGABAPENTINQuality Care Products, LLCANDACurrent
60760-066GabapentinGABAPENTINSt. Mary's Medical Park PharmacyANDACurrent
60760-066GabapentinGABAPENTINSt. Mary's Medical Park PharmacyANDACurrent
60760-067GabapentinGABAPENTINSt. Mary's Medical Park PharmacyANDACurrent
61919-387GABAPENTINGABAPENTINDIRECT RXANDACurrent
63629-8061GabapentinGABAPENTINBryant Ranch PrepackANDACurrent
63629-8061GabapentinGABAPENTINBryant Ranch PrepackANDACurrent
67046-341GabapentinGABAPENTINContract Pharmacy Services-PAANDACurrent
67046-413GabapentinGABAPENTINContract Pharmacy Services-PAANDACurrent
68071-4099GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4099GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4099GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4346GabapentinGABAPENTINNuCare Pharmaceuticals,InANDACurrent
68071-4346GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4346GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7005GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7005GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7005GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7005GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7098GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7098GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7104GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7104GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7104GabapentinGABAPENTINPreferred Pharmaceuticals Inc.ANDACurrent
68788-7288GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7288GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0810GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-0810GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-0810GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-0810GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-0810GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-0810GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-1160GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-1160GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-1160GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-1160GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2098GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2098GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2098GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2098GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70518-2098GabapentinGABAPENTINREMEDYREPACK INC.ANDACurrent
70934-593GabapentinGABAPENTINDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-593GabapentinGABAPENTINDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71093-111GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-111GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-111GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-111GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-111GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-111GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-112GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-112GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-112GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-112GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-112GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71093-112GabapentinGABAPENTINACI Healthcare USA, Inc.ANDACurrent
71205-160GabapentinGABAPENTINProficient Rx LPANDACurrent
71205-160GabapentinGABAPENTINProficient Rx LPANDACurrent
71205-160GabapentinGABAPENTINProficient Rx LPANDACurrent
71205-457GabapentinGABAPENTINProficient Rx LPANDACurrent
71335-1007GabapentinGABAPENTINBryant Ranch PrepackANDACurrent
71335-1007GabapentinGABAPENTINBryant Ranch PrepackANDACurrent
71335-1007GabapentinGABAPENTINBryant Ranch PrepackANDACurrent