Home NDC 81279-126 GABAPENTIN
Product NDC 81279-126
11-digit product format 812790126
Labeler code 81279
Product ID 81279-126_526cf9ed-8502-fed9-e063-6394a90adf42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name GABAPENTIN
Dosage form CAPSULE
Route ORAL
Labeler Pangea Pharmaceuticals, LLC
Application ANDA219319
Marketing category ANDA
Marketing start 2026-05-22
Substance GABAPENTIN
Active strength 200 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 1 .
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 A219319-001 GABAPENTIN GABAPENTIN 100MG CAPSULE / ORAL AB 2025-08-07 A219319-002 GABAPENTIN GABAPENTIN 300MG CAPSULE / ORAL AB 2025-08-07 A219319-003 GABAPENTIN GABAPENTIN 400MG CAPSULE / ORAL AB 2025-08-07 A219319-004 GABAPENTIN GABAPENTIN 200MG CAPSULE / ORAL AB 2026-05-14
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.
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 2026-02-19 14:30 UTC 2026-02 A219319-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2025-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219319-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2025-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A219319-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2025-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219319-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2025-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219319-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2025-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219319-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2025-08-07 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219319-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2025-08-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219319-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2025-08-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219319-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2025-08-07 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219319-004 GABAPENTIN 200MG CAPSULE / ORAL AB 2026-05-14 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base GABAPENTIN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 200 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 2739001 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 81279-126-60 GABAPENTIN 60 in 1 BOTTLE CAPSULE 60 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 · 3 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 81279-126-60 81279012660 60 CAPSULE in 1 BOTTLE (81279-126-60) 60 capsule 2026-05-22 No No Current