Home NDC 80425-0031 Gabapentin
Product NDC 80425-0031
11-digit product format 804250031
Labeler code 80425
Product ID 80425-0031_2a988314-623a-2d61-e063-6294a90a3e84
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form CAPSULE
Route ORAL
Labeler ADVANCED RX OF TENNESSEE, LLC
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 44 .
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 · 132 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 2026-10-15 13:18:30 2026-09 A206943-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2018-05-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206943-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2018-05-14 c2088c7a36db…2026-10-15 13:18:30 2026-09 A206943-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2018-05-14 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 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 80425-0031-1 Gabapentin 30 in 1 BOTTLE CAPSULE 30 5 80425-0031-2 Gabapentin 60 in 1 BOTTLE CAPSULE 60 5 80425-0031-3 Gabapentin 90 in 1 BOTTLE CAPSULE 90 5 80425-0031-4 Gabapentin 120 in 1 BOTTLE CAPSULE 120 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0031 GABAPENTIN CAPSULE [ADVANCED RX OF TENNESSEE, LLC] 5 Current NDC, Legacy NDC, 4 package rows 20250101_af73fbd8-9731-e6bf-e053-2995a90af65d.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 Marketing end Sample Exclude flag Status 80425-0031-1 80425003101 30 CAPSULE in 1 BOTTLE (80425-0031-1) 30 capsule 2018-05-14 0000-00-00 No No Current 80425-0031-2 80425003102 60 CAPSULE in 1 BOTTLE (80425-0031-2) 60 capsule 2018-05-14 0000-00-00 No No Current 80425-0031-3 80425003103 90 CAPSULE in 1 BOTTLE (80425-0031-3) 90 capsule 2018-05-14 0000-00-00 No No Current 80425-0031-4 80425003104 120 CAPSULE in 1 BOTTLE (80425-0031-4) 120 capsule 2023-03-30 No No Current