Home NDC 50228-524 gabapentin
Product NDC 50228-524
11-digit product format 502280524
Labeler code 50228
Product ID 50228-524_3f2e32c6-5993-0189-e063-6294a90a0ff6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form TABLET
Route ORAL
Labeler ScieGen Pharmaceuticals, Inc.
Application ANDA218491
Marketing category ANDA
Marketing start 2025-09-20
Substance GABAPENTIN
Active strength 600 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218491-001 GABAPENTIN GABAPENTIN 300MG TABLET / ORAL AB2 2025-09-19 A218491-002 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL AB2 2025-09-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2026-09-14 22:38:34 2026-08 A218491-001 GABAPENTIN 300MG TABLET / ORAL AB2 2025-09-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 A218491-002 GABAPENTIN 600MG TABLET / ORAL AB2 2025-09-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218491-001 GABAPENTIN 300MG TABLET / ORAL AB2 2025-09-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218491-002 GABAPENTIN 600MG TABLET / ORAL AB2 2025-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218491-001 GABAPENTIN 300MG TABLET / ORAL AB2 2025-09-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218491-002 GABAPENTIN 600MG TABLET / ORAL AB2 2025-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218491-001 GABAPENTIN 300MG TABLET / ORAL AB2 2025-09-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218491-002 GABAPENTIN 600MG TABLET / ORAL AB2 2025-09-19 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218491-001 GABAPENTIN 300MG TABLET / ORAL AB2 2025-09-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218491-002 GABAPENTIN 600MG TABLET / ORAL AB2 2025-09-19 a50c72e98297…
Observed Orange Book normalized TE history# 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 600 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1806380 Internal RxNorm lookup 1806382 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 50228-524-05 gabapentin 500 in 1 BOTTLE TABLET 500 1 50228-524-30 gabapentin 30 in 1 BOTTLE TABLET 30 1 50228-524-90 gabapentin 90 in 1 BOTTLE TABLET 90 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 · 1 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 50228-524-05 50228052405 500 TABLET in 1 BOTTLE (50228-524-05) 500 tablet 2025-09-20 No No Current 50228-524-30 50228052430 30 TABLET in 1 BOTTLE (50228-524-30) 30 tablet 2025-09-20 No No Current 50228-524-90 50228052490 90 TABLET in 1 BOTTLE (50228-524-90) 90 tablet 2025-09-20 No No Current