Home NDC 65162-698-90 Gabapentin
Product NDC 65162-698
Requested package NDC 65162-698-90
11-digit product format 651620698
Labeler code 65162
Product ID 65162-698_bcc054b1-a2fa-40b7-b150-b937763fcf7f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA202024
Marketing category ANDA
Marketing start 2011-09-30
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 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 65162-698 65162-698-90 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A202024-001 GABAPENTIN GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202024-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202024-001 GABAPENTIN 250MG/5ML SOLUTION / ORAL AA 2012-03-23 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65162-698-39 Gabapentin 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 28 65162-698-54 Gabapentin 50 in 1 CARTON SOLUTION 50 28 65162-698-90 Gabapentin 473 mL in 1 BOTTLE SOLUTION 473 28
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM INACTIVE INGREDIENT K679OBS311 GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 POTASSIUM SORBATE INACTIVE INGREDIENT 1VPU26JZZ4 GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-698 GABAPENTIN SOLUTION [AMNEAL PHARMACEUTICALS LLC] 27 Current NDC, Legacy NDC, 3 package rows 20241006_772d9e7a-3811-455a-99e6-f2a3d0769b9b.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 Marketing end Sample Exclude flag Status 65162-698-90 65162069890 473 mL in 1 BOTTLE (65162-698-90) 473 ml 2011-09-30 0000-00-00 No No Current