Home NDC 52427-804 Gralise
Product NDC 52427-804
11-digit product format 524270804
Labeler code 52427
Product ID 52427-804_44a61305-2313-59c4-8a44-98c827461735
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Almatica Pharma LLC
Application NDA022544
Marketing category NDA
Marketing start 2023-12-31
Substance GABAPENTIN
Active strength 450 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022544-001 GRALISE GABAPENTIN 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 N022544-002 GRALISE GABAPENTIN 600MG TABLET / ORAL AB2 RLD 2011-01-28 N022544-003 GRALISE GABAPENTIN 450MG TABLET / ORAL AB RLD 2023-04-18 N022544-004 GRALISE GABAPENTIN 750MG TABLET / ORAL AB RLD 2023-04-18 N022544-005 GRALISE GABAPENTIN 900MG TABLET / ORAL AB RLD, RS 2023-04-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 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 · 142 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 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022544-003 GRALISE 450MG TABLET / ORAL AB RLD 2023-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022544-004 GRALISE 750MG TABLET / ORAL AB RLD 2023-04-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022544-005 GRALISE 900MG TABLET / ORAL AB RLD, RS 2023-04-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022544-003 GRALISE 450MG TABLET / ORAL AB RLD 2023-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022544-004 GRALISE 750MG TABLET / ORAL AB RLD 2023-04-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022544-005 GRALISE 900MG TABLET / ORAL AB RLD, RS 2023-04-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022544-003 GRALISE 450MG TABLET / ORAL RLD 2023-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022544-004 GRALISE 750MG TABLET / ORAL RLD 2023-04-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022544-005 GRALISE 900MG TABLET / ORAL RLD, RS 2023-04-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022544-003 GRALISE 450MG TABLET / ORAL RLD 2023-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022544-004 GRALISE 750MG TABLET / ORAL RLD 2023-04-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022544-005 GRALISE 900MG TABLET / ORAL RLD, RS 2023-04-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022544-003 GRALISE 450MG TABLET / ORAL RLD 2023-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022544-004 GRALISE 750MG TABLET / ORAL RLD 2023-04-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022544-005 GRALISE 900MG TABLET / ORAL RLD, RS 2023-04-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-003 GRALISE 450MG TABLET / ORAL RLD 2023-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-004 GRALISE 750MG TABLET / ORAL RLD 2023-04-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-005 GRALISE 900MG TABLET / ORAL RLD, RS 2023-04-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-003 GRALISE 450MG TABLET / ORAL RLD 2023-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-004 GRALISE 750MG TABLET / ORAL RLD 2023-04-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-005 GRALISE 900MG TABLET / ORAL RLD, RS 2023-04-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-001 GRALISE 300MG TABLET / ORAL AB2 RLD, RS 2011-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-002 GRALISE 600MG TABLET / ORAL AB2 RLD 2011-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-003 GRALISE 450MG TABLET / ORAL RLD 2023-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-004 GRALISE 750MG TABLET / ORAL RLD 2023-04-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-005 GRALISE 900MG TABLET / ORAL RLD, RS 2023-04-18 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 91 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 244 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022544-002 7438927 2024-02-26 U-1114 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022544-002 7438927 2024-02-26 U-1114 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022544-002 7438927 2024-02-26 U-1114 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022544-002 7438927 2024-02-26 U-1114 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022544-002 7438927 2024-02-26 U-1114 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022544-002 7438927 2024-02-26 U-1114 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022544-002 7438927 2024-02-26 U-1114 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022544-002 7438927 2024-02-26 U-1114 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022544-002 7438927 2024-02-26 U-1114 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-001 7731989 2022-10-25 Drug product 2011-03-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-001 8192756 2022-10-25 U-1114 Drug product 2012-06-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-001 8252332 2022-10-25 U-1114 Drug product 2012-09-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-001 8333992 2022-10-25 U-1114 Drug product 2013-01-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-002 7731989 2022-10-25 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-002 8192756 2022-10-25 U-1114 Drug product 2012-06-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-002 8252332 2022-10-25 U-1114 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-002 8333992 2022-10-25 U-1114 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022544-002 7438927 2024-02-26 U-1114 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022544-001 7731989 2022-10-25 Drug product 2011-03-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-001 8192756 2022-10-25 U-1114 Drug product 2012-06-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-001 8252332 2022-10-25 U-1114 Drug product 2012-09-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-001 8333992 2022-10-25 U-1114 Drug product 2013-01-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-001 7438927 2024-02-26 U-1114 2011-03-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-002 7731989 2022-10-25 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-002 8192756 2022-10-25 U-1114 Drug product 2012-06-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-002 8252332 2022-10-25 U-1114 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-002 8333992 2022-10-25 U-1114 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022544-002 7438927 2024-02-26 U-1114 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022544-001 7731989 2022-10-25 Drug product 2011-03-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022544-001 8192756 2022-10-25 U-1114 Drug product 2012-06-08 4b0b4de00fa7…
Additional Listing Data#
Finished product Yes
Brand name base Gralise
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GABAPENTIN 450 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 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1115012 Internal RxNorm lookup 1115013 Internal RxNorm lookup 1806380 Internal RxNorm lookup 1806382 Internal RxNorm lookup 2398511 Internal RxNorm lookup 2398512 Internal RxNorm lookup 2634743 Internal RxNorm lookup 2634745 Internal RxNorm lookup 2634747 Internal RxNorm lookup 2634749 Internal RxNorm lookup 2634751 Internal RxNorm lookup 2634753 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 52427-804-60 Gralise 60 in 1 BOTTLE TABLET, FILM COATED 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52427-804 GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE (GABAPENTIN) KIT [ALMATICA PHARMA LLC] 5 Current NDC, 1 package rows 20240704_466273b1-c9fc-3930-c94b-aa11394d5140.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 Marketing start Sample Exclude flag Status 52427-804-60 52427080460 60 TABLET, FILM COATED in 1 BOTTLE (52427-804-60) 2023-12-31 No No Current