Home NDC 71335-3109 GABAPENTIN
Product NDC 71335-3109
11-digit product format 713353109
Labeler code 71335
Product ID 71335-3109_bb3a5eaa-e6d8-485e-9578-05c8f7701899
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA211314
Marketing category ANDA
Marketing start 2018-10-17
Substance GABAPENTIN
Active strength 300 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 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 A211314-001 GABAPENTIN GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 A211314-002 GABAPENTIN GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 A211314-003 GABAPENTIN GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16
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 4 · 129 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 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211314-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211314-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211314-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-10-16 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 300 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 310431 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 71335-3109-1 GABAPENTIN 500 in 1 BOTTLE CAPSULE 500 1
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 71335-3109-1 71335310901 500 CAPSULE in 1 BOTTLE (71335-3109-1) 500 capsule 2018-10-17 No No Current