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
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
ndc (product): 60687-580
ndc (product): 60687-591
ndc (product): 60687-602
GabapentinGABAPENTINMcKesson Corporation dba Sky Packaging23eb133e-2f74-4219-9892-0a8e770ec0322025-04-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
ndc (product): 63739-904
ndc (product): 63739-903
ndc (product): 63739-902
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
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a072d5d2-8c75-59cc-e053-2a95a90ac0cc2024-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
ndc (product): 68071-5193
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
GabapentinGABAPENTINAsclemed USA, Inc.14b1840d-a2db-4eec-bc25-029e35b042e42022-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINProficient Rx LP2ef99c3d-866a-438b-a340-8beba8d4c4572019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
ndc (product): 63187-810
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCf455b415-12a2-4916-b826-246976a8af442018-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC6fc8e8b2-5d0e-4c72-9a46-6d312c3efac72018-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090858
application number: ANDA090858

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 2 of 4 · 241 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55700-544GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-584GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-584GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-584GabapentinGabapentinLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-584GabapentinGabapentinQuality Care Products LLCANDACurrent
55700-812GabapentinGabapentinQuality Care Products, LLCANDACurrent
55700-812GabapentinGabapentinQuality Care Products, LLCANDACurrent
55700-812GabapentinGabapentinQuality Care Products, LLCANDACurrent
55700-812GabapentinGabapentinQuality Care Products, LLCANDACurrent
55700-812GabapentinGabapentinQuality Care Products, LLCANDACurrent
60687-580GabapentinGabapentinAmerican Health PackagingANDACurrent
60687-580GabapentinGabapentinAmerican Health PackagingANDACurrent
60687-591GabapentinGabapentinAmerican Health PackagingANDACurrent
60687-591GabapentinGabapentinAmerican Health PackagingANDACurrent
60687-602GabapentinGabapentinAmerican Health PackagingANDACurrent
60687-602GabapentinGabapentinAmerican Health PackagingANDACurrent
60760-857GabapentinGabapentinSt. Mary's Medical Park PharmacyANDACurrent
63187-810GabapentinGabapentinProficient Rx LPANDACurrent
63187-810GabapentinGabapentinProficient Rx LPANDACurrent
63187-810GabapentinGabapentinProficient Rx LPANDACurrent
63739-902GabapentinGabapentinMcKesson Corporation dba Sky PackagingANDACurrent
63739-903GabapentinGabapentinMcKesson Corporation dba Sky PackagingANDACurrent
63739-904GabapentinGabapentinMcKesson Corporation dba Sky PackagingANDACurrent
67046-225GabapentinGabapentinContract Pharmacy Services-PAANDACurrent
67046-226GabapentinGabapentinContract Pharmacy Services-PAANDACurrent
67046-232GabapentinGabapentinContract Pharmacy Services-PAANDACurrent
67296-1142GabapentinGabapentinRedPharm Drug, Inc.ANDACurrent
67296-1142GabapentinGabapentinRedPharm Drug, Inc.ANDACurrent
67296-1142GabapentinGabapentinRedPharm Drug, Inc.ANDACurrent
67877-222GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-222GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-222GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-222GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-222GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-222GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-223GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-223GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-223GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-223GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-223GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-223GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-224GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-224GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-224GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-224GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-224GabapentinGabapentinAscend Laboratories, LLCANDACurrent
67877-224GabapentinGabapentinAscend Laboratories, LLCANDACurrent
68071-4729GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4729GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5193GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5193GabapentinGabapentinNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7043GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7043GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7043GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7043GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7043GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7044GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7044GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7044GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7044GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7044GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7119GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7119GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7119GabapentinGabapentinPreferred Pharmaceuticals Inc.ANDACurrent
68788-7777GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7777GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7777GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9509GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9509GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9509GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9509GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9509GabapentinGabapentinPreferred Pharmaceuticals, Inc.ANDACurrent
69176-100Cyclo/Gaba 10/300 PackCyclo/Gaba 10/300 PackTMIG Inc.ANDACurrent
69176-200GabapentinGabapentinTMIG Inc.ANDACurrent
69189-0683GabapentinGabapentinAvera McKennan HospitalANDACurrent
70518-0053GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0053GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0053GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0053GabapentinGabapentinREMEDYREPACK INC.ANDACurrent
70518-0053GabapentinGabapentinREMEDYREPACK INC.ANDACurrent