Home NDC 42385-973 Gabapentin
Product NDC 42385-973
11-digit product format 423850973
Labeler code 42385
Product ID 42385-973_7a649a0a-d3ca-48e4-af76-f9adf3fa6c4d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form CAPSULE
Route ORAL
Labeler Laurus Labs Limited
Application ANDA217546
Marketing category ANDA
Marketing start 2023-05-13
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 1 .
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 A217546-001 GABAPENTIN GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 A217546-002 GABAPENTIN GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 A217546-003 GABAPENTIN GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12
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 2 · 66 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 2026-02-19 14:30 UTC 2026-02 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217546-002 GABAPENTIN 300MG CAPSULE / ORAL AB 2023-05-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217546-003 GABAPENTIN 400MG CAPSULE / ORAL AB 2023-05-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217546-001 GABAPENTIN 100MG CAPSULE / ORAL AB 2023-05-12 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310430 Internal RxNorm lookup 310431 Internal RxNorm lookup 310432 Internal RxNorm lookup 310433 Internal RxNorm lookup 310434 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42385-973 GABAPENTIN CAPSULE [LAURUS LABS LIMITED] 2 Current NDC, 7 package rows 20240530_07aa1bcc-df05-44fa-92d4-63894e0e6cd6.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 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 42385-973-01 42385097301 100 CAPSULE in 1 BOTTLE (42385-973-01) 100 capsule 2023-05-13 No No Current 42385-973-05 42385097305 500 CAPSULE in 1 BOTTLE (42385-973-05) 500 capsule 2023-05-13 No No Current 42385-973-11 42385097311 1000 CAPSULE in 1 BOTTLE (42385-973-11) 1000 capsule 2023-05-13 No No Current 42385-973-30 42385097330 30 CAPSULE in 1 BOTTLE (42385-973-30) 30 capsule 2023-05-13 No No Current 42385-973-72 42385097372 10 BLISTER PACK in 1 CARTON (42385-973-72) / 10 CAPSULE in 1 BLISTER PACK 10 blister pack 2023-05-13 No No Current 42385-973-90 42385097390 90 CAPSULE in 1 BOTTLE (42385-973-90) 90 capsule 2023-05-13 No No Current