Home NDC 72162-2139-9 Gabapentin
Product NDC 72162-2139
Requested package NDC 72162-2139-9
11-digit product format 721622139
Labeler code 72162
Product ID 72162-2139_8513f8ab-cf2a-4654-b0b3-91640b319168
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form CAPSULE
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA206943
Marketing category ANDA
Marketing start 2018-05-14
Substance GABAPENTIN
Active strength 300 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 A206943-001 GABAPENTIN GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 A206943-002 GABAPENTIN GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 A206943-003 GABAPENTIN GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14
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 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 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 2026-12-31 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 72162-2139-1 Gabapentin 100 in 1 BOTTLE, PLASTIC CAPSULE 100 104 72162-2139-2 Gabapentin 270 in 1 BOTTLE, PLASTIC CAPSULE 270 104 72162-2139-3 Gabapentin 30 in 1 BOTTLE, PLASTIC CAPSULE 30 104 72162-2139-5 Gabapentin 500 in 1 BOTTLE, PLASTIC CAPSULE 500 104 72162-2139-9 Gabapentin 90 in 1 BOTTLE, PLASTIC CAPSULE 90 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2139 GABAPENTIN CAPSULE [BRYANT RANCH PREPACK] 104 Current NDC, 5 package rows 20241020_fb0b6613-57d6-4e24-946f-f5f87c460cf0.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 2 of 2 · 25 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 72162-2139-9 72162213909 90 CAPSULE in 1 BOTTLE, PLASTIC (72162-2139-9) 90 capsule 2023-10-12 No No Current