Home NDC 0378-5246 Almotriptan Malate
Product NDC 0378-5246
11-digit product format 003785246
Labeler code 0378
Product ID 0378-5246_24da4379-1283-4c66-97bd-643b27a15368
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Almotriptan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA205171
Marketing category ANDA
Marketing start 2015-11-10
Substance ALMOTRIPTAN MALATE
Active strength 12.5 mg/1
Pharmacologic classes Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
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 A205171-001 ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 A205171-002 ALMOTRIPTAN MALATE ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09
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.
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 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205171-001 ALMOTRIPTAN MALATE EQ 6.25MG BASE TABLET / ORAL AB 2015-11-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A205171-002 ALMOTRIPTAN MALATE EQ 12.5MG BASE TABLET / ORAL AB 2015-11-09 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Almotriptan Malate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALMOTRIPTAN MALATE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination PJP312605E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 284204 Internal RxNorm lookup 284205 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 0378-5246-32 Almotriptan Malate 6 in 1 BLISTER PACK TABLET, FILM COATED 6 4 0378-5246-85 Almotriptan Malate 2 in 1 CARTON TABLET, FILM COATED 2 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALMOTRIPTAN MALATE ACTIVE INGREDIENT PJP312605E ALMOTRIPTAN MALATE (ALMOTRIPTAN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 ALMOTRIPTAN ACTIVE MOIETY 1O4XL5SN61 ALMOTRIPTAN MALATE (ALMOTRIPTAN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ALMOTRIPTAN MALATE (ALMOTRIPTAN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ALMOTRIPTAN MALATE (ALMOTRIPTAN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ALMOTRIPTAN MALATE (ALMOTRIPTAN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ALMOTRIPTAN MALATE (ALMOTRIPTAN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E ALMOTRIPTAN MALATE (ALMOTRIPTAN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ALMOTRIPTAN MALATE (ALMOTRIPTAN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI ALMOTRIPTAN MALATE (ALMOTRIPTAN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ALMOTRIPTAN MALATE (ALMOTRIPTAN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-5246 ALMOTRIPTAN MALATE (ALMOTRIPTAN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 Current NDC, Legacy NDC, 2 package rows 20180926_35617039-9f33-401b-bac3-8f85c65fa2c7.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 Marketing end Sample Exclude flag Status 0378-5246-32 00378524632 6 in 1 BLISTER PACK Historical 0378-5246-85 00378524685 2 BLISTER PACK in 1 CARTON (0378-5246-85) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-5246-32) 2 blister pack 2015-11-10 0000-00-00 No No Current