Home NDC 17856-0600 Gabapentin
Product NDC 17856-0600
11-digit product format 178560600
Labeler code 17856
Product ID 17856-0600_361f9f34-f186-da49-e063-6394a90a3d51
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form SOLUTION
Route ORAL
Labeler ATLANTIC BIOLOGICALS CORP.
Application ANDA076403
Marketing category ANDA
Marketing start 2018-06-29
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 17856-0600-7 excluded package package 17856-0600-1 excluded package package 17856-0600-2
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 A076403-001 GABAPENTIN GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076403-001 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 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076403-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-05-01 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17856-0600 GABAPENTIN SOLUTION [ATLANTIC BIOLOGICALS CORP.] 7 Current NDC, Legacy NDC, 9 package rows 20250529_5969f1a8-d6d5-4967-add5-4e2492354d7b.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 17856-0600-1 17856060001 72 CUP, UNIT-DOSE in 1 BOX (17856-0600-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0600-4) 2024-05-07 0000-00-00 No No Current 17856-0600-2 17856060002 72 CUP, UNIT-DOSE in 1 BOX (17856-0600-2) / 6 mL in 1 CUP, UNIT-DOSE (17856-0600-5) 2024-05-07 0000-00-00 No No Current 17856-0600-3 17856060003 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0600-3) > 2 mL in 1 SYRINGE 120 syringe 2021-02-08 0000-00-00 No No Current 17856-0600-4 17856060004 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 17856-0600-5 17856060005 6 mL in 1 CUP, UNIT-DOSE 6 ml Historical 17856-0600-6 17856060006 2 mL in 1 SYRINGE 2 ml Historical 17856-0600-7 17856060007 5 BOX, UNIT-DOSE in 1 SYRINGE (17856-0600-7) / 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0600-3) / 2 mL in 1 SYRINGE (17856-0600-6) 2024-05-07 0000-00-00 No No Current 17856-0600-8 17856060008 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0600-8) / 2 mL in 1 SYRINGE (17856-0600-9) 60 syringe 2025-02-05 No No Current 17856-0600-9 17856060009 2 mL in 1 SYRINGE 2 ml Historical