Home NDC 74157-111 GABARONE
Product NDC 74157-111
11-digit product format 741570111
Labeler code 74157
Product ID 74157-111_47d9ab92-3736-01a7-e063-6394a90a7c55
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form TABLET
Route ORAL
Labeler INA Pharmaceutics Inc.
Application ANDA211313
Marketing category ANDA
Marketing start 2024-12-23
Substance GABAPENTIN
Active strength 400 mg/1
Pharmacologic classes Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211313-001 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 A211313-002 GABAPENTIN GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 A211313-003 GABAPENTIN GABAPENTIN 100MG TABLET / ORAL AB1 2024-12-20 A211313-004 GABAPENTIN GABAPENTIN 400MG TABLET / ORAL AB1 2024-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 2026-08-18 06:07:40 2026-07 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211313-003 GABAPENTIN 100MG TABLET / ORAL AB1 2024-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211313-004 GABAPENTIN 400MG TABLET / ORAL AB1 2024-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211313-003 GABAPENTIN 100MG TABLET / ORAL AB1 2024-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211313-004 GABAPENTIN 400MG TABLET / ORAL AB1 2024-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211313-003 GABAPENTIN 100MG TABLET / ORAL AB1 2024-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211313-004 GABAPENTIN 400MG TABLET / ORAL AB1 2024-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211313-003 GABAPENTIN 100MG TABLET / ORAL AB1 2024-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211313-004 GABAPENTIN 400MG TABLET / ORAL AB1 2024-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211313-003 GABAPENTIN 100MG TABLET / ORAL AB1 2024-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211313-004 GABAPENTIN 400MG TABLET / ORAL AB1 2024-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211313-003 GABAPENTIN 100MG TABLET / ORAL AB1 2024-12-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211313-004 GABAPENTIN 400MG TABLET / ORAL AB1 2024-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211313-003 GABAPENTIN 100MG TABLET / ORAL AB1 2024-12-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211313-004 GABAPENTIN 400MG TABLET / ORAL AB1 2024-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211313-001 GABAPENTIN 600MG TABLET / ORAL AB1 2024-03-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211313-002 GABAPENTIN 800MG TABLET / ORAL AB1 2024-03-04 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 50 observed states.
Additional Listing Data#
Finished product Yes
Brand name base GABARONE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 400 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 476673 Internal RxNorm lookup 476679 Internal RxNorm lookup 602399 Internal RxNorm lookup 602407 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 74157-111-90 GABARONE 90 in 1 BOTTLE TABLET 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 74157-111 GABARONE (GABAPENTIN) TABLET [INA PHARMACEUTICS INC.] 1 Current NDC, 1 package rows 20241225_0f350a4b-f294-4b98-b69f-3cc789e930ba.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 74157-111-90 74157011190 90 TABLET in 1 BOTTLE (74157-111-90) 90 tablet 2024-12-23 No No Current