Home NDC 63187-785 Gabapentin
Product NDC 63187-785
11-digit product format 631870785
Labeler code 63187
Product ID 63187-785_1f31e7f3-c013-4492-90ac-481c23448403
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Gabapentin
Dosage form TABLET
Route ORAL
Labeler Proficient Rx LP
Application ANDA202764
Marketing category ANDA
Marketing start 2016-07-22
Substance GABAPENTIN
Active strength 600 mg/1
Pharmacologic classes Anti-epileptic Agent [EPC], 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202764-001 GABAPENTIN GABAPENTIN 600MG TABLET / ORAL 2012-10-16 A202764-002 GABAPENTIN GABAPENTIN 800MG TABLET / ORAL 2012-10-16
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 3 · 82 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 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202764-001 GABAPENTIN 600MG TABLET / ORAL 2012-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202764-002 GABAPENTIN 800MG TABLET / ORAL 2012-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202764-001 GABAPENTIN 600MG TABLET / ORAL AB 2012-10-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A202764-002 GABAPENTIN 800MG TABLET / ORAL AB 2012-10-16 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310433 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 63187-785-00 Gabapentin 100 in 1 BOTTLE TABLET 100 3 63187-785-30 Gabapentin 30 in 1 BOTTLE TABLET 30 3 63187-785-60 Gabapentin 60 in 1 BOTTLE TABLET 60 3 63187-785-72 Gabapentin 120 in 1 BOTTLE TABLET 120 3 63187-785-90 Gabapentin 90 in 1 BOTTLE TABLET 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-785 GABAPENTIN TABLET [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 5 package rows 20210114_f6baeb5c-ca9c-4730-aeb8-8f8732e8ca3a.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 · 3 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 63187-785-00 63187078500 100 TABLET in 1 BOTTLE (63187-785-00) 100 tablet 2016-12-01 0000-00-00 No No Current 63187-785-30 63187078530 30 TABLET in 1 BOTTLE (63187-785-30) 30 tablet 2016-12-01 0000-00-00 No No Current 63187-785-60 63187078560 60 TABLET in 1 BOTTLE (63187-785-60) 60 tablet 2016-12-01 0000-00-00 No No Current 63187-785-72 63187078572 120 TABLET in 1 BOTTLE (63187-785-72) 120 tablet 2016-12-01 0000-00-00 No No Current 63187-785-90 63187078590 90 TABLET in 1 BOTTLE (63187-785-90) 90 tablet 2016-12-01 0000-00-00 No No Current