Application 090858

Type
ANDA
Sponsor
ALKEM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINCAPSULE;ORAL100MGNoNo
002GABAPENTINGABAPENTINCAPSULE;ORAL300MGNoNo
003GABAPENTINGABAPENTINCAPSULE;ORAL400MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090858-001GABAPENTINGABAPENTIN100MGCAPSULE / ORALAB2010-12-17
A090858-002GABAPENTINGABAPENTIN300MGCAPSULE / ORALAB2010-12-17
A090858-003GABAPENTINGABAPENTIN400MGCAPSULE / ORALAB2010-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A090858-001AB
A090858-002AB
A090858-003AB

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17c2088c7a36db…
2026-10-15 13:18:302026-09A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17c2088c7a36db…
2026-10-15 13:18:302026-09A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17c2088c7a36db…
2026-09-14 22:38:342026-08A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1784e616aacf4f…
2026-09-14 22:38:342026-08A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1784e616aacf4f…
2026-09-14 22:38:342026-08A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1784e616aacf4f…
2026-08-18 06:07:402026-07A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17caaa826d4ba7…
2026-08-18 06:07:402026-07A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-002GABAPENTIN300MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-003GABAPENTIN400MGCAPSULE / ORALAB2010-12-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-001GABAPENTIN100MGCAPSULE / ORALAB2010-12-1779d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A090858-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A090858-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A090858-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A090858-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090858-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090858-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A090858-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090858-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090858-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090858-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090858-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090858-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090858-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090858-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090858-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090858-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090858-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090858-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090858-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090858-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090858-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090858-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090858-001AB179d66fd596c7…

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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINAdvanced Rx of Tennessee, LLCafc83432-8fce-6d2a-e053-2a95a90ae73f2026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
ndc (product): 80425-0033
GabapentinGABAPENTINA-S Medication Solutionsc979f80b-d4b1-40f7-b878-b216db5f325d2026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINAmerican Health Packagingbbfdedd7-2baf-4bc6-be59-548a5cf217522025-10-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINMcKesson Corporation dba Sky Packaging23eb133e-2f74-4219-9892-0a8e770ec0322025-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINClinical Solutions Wholesale, LLC743faa18-5e7c-4fcc-9781-4157450d90c42025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINAdvanced Rx Pharmacy of Tennessee, LLCc89a68b6-6dc0-4624-e053-2a95a90a687e2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
ndc (product): 80425-0163
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a072d5d2-8c75-59cc-e053-2a95a90ac0cc2024-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINA-S Medication Solutions77d1d90d-e124-4db7-b811-754d535e579c2023-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINProficient Rx LP176c5b60-93c2-4574-8b51-c15180912aaa2022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
ndc (product): 71205-485
GabapentinGABAPENTINAsclemed USA, Inc.14b1840d-a2db-4eec-bc25-029e35b042e42022-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
ndc (product): 76420-234
ndc (product): 76420-047
GabapentinGABAPENTINProficient Rx LP2ef99c3d-866a-438b-a340-8beba8d4c4572019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCf455b415-12a2-4916-b826-246976a8af442018-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
ndc (product): 71610-143
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC6fc8e8b2-5d0e-4c72-9a46-6d312c3efac72018-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
ndc (product): 71610-059

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 3 of 4 · 241 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70518-0053GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0293GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0293GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0293GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0293GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0293GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0293GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0293GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1469GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1469GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1469GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1469GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1469GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1469GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1469GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1760GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1760GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1760GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1760GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1760GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1760GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1760GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1760GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1760GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1760GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1834GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1834GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1834GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-1834GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2614GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2614GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2614GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2614GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2614GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2614GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2614GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-2614GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-3329GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-3329GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-3330GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70934-123GabapentinGabapentinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-123GabapentinGabapentinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-339GabapentinGabapentinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-339GabapentinGabapentinDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-339GabapentinGabapentinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-827GabapentinGabapentinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-953GabapentinGabapentinDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-485GabapentinGabapentinProficient Rx LPANDACurrent
71205-485GabapentinGabapentinProficient Rx LPANDACurrent
71335-1197GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1197GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1197GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1198GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1198GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1198GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1199GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1199GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1199GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1269GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1269GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1269GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1269GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1496GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1496GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-1496GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-2053GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-2053GabapentinGabapentinBryant Ranch PrepackANDACurrent
71335-2053GabapentinGabapentinBryant Ranch PrepackANDACurrent
71610-059GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-143GabapentinGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
76420-047GabapentinGabapentinAsclemed USA, Inc.ANDACurrent
76420-047GabapentinGabapentinAsclemed USA, Inc.ANDACurrent
76420-234GabapentinGabapentinAsclemed USA, Inc.ANDACurrent
80425-0033NeurontinGabapentin 300mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0033NeurontinGabapentin 300mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0033GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0033GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0033GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0163NeurontinGabapentin 300mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0163GabapentinGabapentinAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent