Home NDC 13913-005-19 Gralise
Product NDC 13913-005
Requested package NDC 13913-005-19
11-digit product format 139130005
Labeler code 13913
Product ID 13913-005_b7c67fdf-a947-292f-eef0-033f21d9616d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name gabapentin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Assertio Therapeutics, Inc.
Application NDA022544
Marketing category NDA
Marketing start 2011-01-28
Marketing end 2023-09-30
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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GABAPENTIN ACTIVE INGREDIENT 6CW7F3G59X GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 GABAPENTIN ACTIVE MOIETY 6CW7F3G59X GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 COPOVIDONE INACTIVE INGREDIENT D9C330MD8B GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 TALC INACTIVE INGREDIENT 7SEV7J4R1U GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE STARTER PACK (GABAPENTIN) KIT [DEPOMED, INC.] 7
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gralise GABAPENTIN Almatica Pharma LLC 466273b1-c9fc-3930-c94b-aa11394d5140 2025-05-01 Warnings, Adverse reactions Exact identifier application applno (NDA): 022544 application number: NDA022544
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 13913-005-19 13913000519 90 TABLET, FILM COATED in 1 BOTTLE (13913-005-19) 2011-01-28 2023-09-30 No No Current