Home NDC 71335-2478 Gabapentin
Product NDC 71335-2478
11-digit product format 713352478
Labeler code 71335
Product ID 71335-2478_2973d72c-9629-418f-8443-47ca3a54d352
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA213603
Marketing category ANDA
Marketing start 2021-05-03
Substance GABAPENTIN
Active strength 400 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213603-001 GABAPENTIN GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 A213603-002 GABAPENTIN GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 A213603-003 GABAPENTIN GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 3 · 117 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 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213603-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2020-08-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213603-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2020-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213603-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2020-08-17 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310432 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-2478 GABAPENTIN CAPSULE [BRYANT RANCH PREPACK] 1 Current NDC, 10 package rows 20240906_2dad630a-09d8-4f40-bdad-24e877a9ee38.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 · 4 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 71335-2478-0 71335247800 180 CAPSULE in 1 BOTTLE (71335-2478-0) 180 capsule 2024-09-03 No No Current 71335-2478-1 71335247801 20 CAPSULE in 1 BOTTLE (71335-2478-1) 20 capsule 2024-09-03 No No Current 71335-2478-2 71335247802 90 CAPSULE in 1 BOTTLE (71335-2478-2) 90 capsule 2024-09-03 No No Current 71335-2478-3 71335247803 60 CAPSULE in 1 BOTTLE (71335-2478-3) 60 capsule 2024-09-03 No No Current 71335-2478-4 71335247804 30 CAPSULE in 1 BOTTLE (71335-2478-4) 30 capsule 2024-09-03 No No Current 71335-2478-5 71335247805 120 CAPSULE in 1 BOTTLE (71335-2478-5) 120 capsule 2024-09-03 No No Current 71335-2478-6 71335247806 21 CAPSULE in 1 BOTTLE (71335-2478-6) 21 capsule 2024-09-03 No No Current 71335-2478-7 71335247807 84 CAPSULE in 1 BOTTLE (71335-2478-7) 84 capsule 2024-09-03 No No Current 71335-2478-8 71335247808 112 CAPSULE in 1 BOTTLE (71335-2478-8) 112 capsule 2024-09-03 No No Current 71335-2478-9 71335247809 28 CAPSULE in 1 BOTTLE (71335-2478-9) 28 capsule 2024-09-03 No No Current