Home NDC 70010-228-05 Gabapentin
Product NDC 70010-228
Requested package NDC 70010-228-05
11-digit product format 700100228
Labeler code 70010
Product ID 70010-228_3513f676-25fe-02db-e063-6294a90a1f9d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Granules Pharmaceuticals Inc.
Application ANDA217116
Marketing category ANDA
Marketing start 2023-06-27
Substance GABAPENTIN
Active strength 800 mg/1
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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217116-001 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 A217116-002 GABAPENTIN GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 50 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 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB1 2023-03-28 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB1 2023-03-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB 2023-03-28 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB 2023-03-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217116-001 GABAPENTIN 600MG TABLET / ORAL AB 2023-03-28 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217116-002 GABAPENTIN 800MG TABLET / ORAL AB 2023-03-28 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 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 800 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310433 Internal RxNorm lookup 310434 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 70010-228-01 Gabapentin 100 in 1 BOTTLE TABLET, FILM COATED 100 4 70010-228-05 Gabapentin 500 in 1 BOTTLE TABLET, FILM COATED 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70010-228 GABAPENTIN TABLET, FILM COATED [GRANULES PHARMACEUTICALS INC.] 3 Current NDC, 2 package rows 20241018_e847bcfa-f3de-404a-8a57-d8a414691e6a.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 Marketing start Sample Exclude flag Status 70010-228-05 70010022805 500 TABLET, FILM COATED in 1 BOTTLE (70010-228-05) 2023-06-27 No No Current