Home NDC 0121-1067 Gabapentin
Product NDC 0121-1067
11-digit product format 001211067
Labeler code 0121
Product ID 0121-1067_01ef9bd4-78c9-4ec7-8633-c4e0260ad2de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application ANDA211330
Marketing category ANDA
Marketing start 2025-06-12
Substance GABAPENTIN
Active strength 250 mg/5mL
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 1 .
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 A211330-001 GABAPENTIN GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2019-12-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211330-001 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.
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 2026-02-19 14:30 UTC 2026-02 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2019-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2019-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2019-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2019-12-03 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL 2019-12-03 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211330-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2019-12-03 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Gabapentin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 250 mg/5mL
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 0121-1067-16 Gabapentin 470 mL in 1 BOTTLE, PLASTIC SOLUTION 470 3
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 · 2 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 0121-1067-16 00121106716 470 mL in 1 BOTTLE, PLASTIC (0121-1067-16) 470 ml 2025-06-12 No No Current