Home NDC 44523-120 Gabapentin
Product NDC 44523-120
11-digit product format 445230120
Labeler code 44523
Product ID 44523-120_462c7cf4-92a8-cf81-e063-6294a90a43c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form SOLUTION
Route ORAL
Labeler BioComp Pharma, Inc.
Application ANDA078974
Marketing category ANDA
Marketing start 2023-11-30
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 A078974-001 GABAPENTIN GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078974-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078974-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2011-02-18 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 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 44523-120-16 Gabapentin 470 mL in 1 BOTTLE SOLUTION 470 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 44523-120 GABAPENTIN SOLUTION [BIOCOMP PHARMA, INC.] 5 Current NDC, 1 package rows 20240622_0b3a4009-42f3-c84f-e063-6294a90a8068.zip
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 · 1 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 44523-120-16 44523012016 470 mL in 1 BOTTLE (44523-120-16) 470 ml 2023-11-30 No No Current