Home NDC 81033-124 Gabapentin
Product NDC 81033-124
11-digit product format 810330124
Labeler code 81033
Product ID 81033-124_3f2ba3d6-6087-eaf2-e063-6294a90a7642
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form SOLUTION
Route ORAL
Labeler Kesin Pharma Corporation
Application ANDA091286
Marketing category ANDA
Marketing start 2025-08-06
Substance GABAPENTIN
Active strength 50 mg/mL
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091286-001 GABAPENTIN GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091286-001 AA
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 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091286-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2016-03-14 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Gabapentin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 50 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 6CW7F3G59X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283523 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81033-124-06 Gabapentin 6 mL in 1 CUP, UNIT-DOSE SOLUTION 6 1 81033-124-44 Gabapentin 40 in 1 CARTON SOLUTION 40 1
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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81033-124-06 81033012406 6 mL in 1 CUP, UNIT-DOSE 6 ml Historical 81033-124-44 81033012444 40 CUP, UNIT-DOSE in 1 CARTON (81033-124-44) / 6 mL in 1 CUP, UNIT-DOSE (81033-124-06) 2025-09-01 No No Current