Almotriptan Malate

Product NDC
0378-5245
11-digit product format
003785245
Labeler code
0378
Product ID
0378-5245_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
6.25 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205171-001ALMOTRIPTAN MALATEALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-09
A205171-002ALMOTRIPTAN MALATEALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A205171-001AB
A205171-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205171-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-11-09782e0a99824c…
2021-12-28 21:50 UTC2021-12A205171-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-11-09782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A205171-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205171-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205171-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205171-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205171-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205171-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205171-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205171-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205171-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205171-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205171-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205171-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205171-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205171-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205171-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205171-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205171-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205171-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205171-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205171-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205171-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205171-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205171-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205171-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205171-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205171-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205171-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205171-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205171-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205171-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205171-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205171-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205171-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205171-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205171-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205171-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205171-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205171-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205171-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205171-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Almotriptan Malate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALMOTRIPTAN MALATE6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PJP312605EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
284204Internal RxNorm lookup
284205Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
35617039-9f33-401b-bac3-8f85c65fa2c7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
30fbb296-209a-3489-3171-031dc496d974Product name520201015
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-5245-32Almotriptan Malate6 in 1 BLISTER PACKTABLET, FILM COATED64
0378-5245-85Almotriptan Malate1 in 1 CARTONTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-5245-32EA - Each0378-5245224bcdb9-2ff3-4866-9935-25ef384d3eb012016-06-14
0378-5245-85EA - Each0378-5245cc209886-ba39-47dc-ae53-57007a6adc6612015-12-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-5245ALMOTRIPTAN MALATE (ALMOTRIPTAN) TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 2 package rows20180926_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Almotriptan MalateALMOTRIPTANMylan Pharmaceuticals Inc.35617039-9f33-401b-bac3-8f85c65fa2c72017-05-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205171
application number: ANDA205171
ndc (product): 0378-5245

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284205almotriptan malate 12.5 MG Oral TabletPSN35617039-9f33-401b-bac3-8f85c65fa2c74
284204almotriptan malate 6.25 MG Oral TabletPSN35617039-9f33-401b-bac3-8f85c65fa2c74
284205almotriptan 12.5 MG Oral TabletSCD35617039-9f33-401b-bac3-8f85c65fa2c74
284204almotriptan 6.25 MG Oral TabletSCD35617039-9f33-401b-bac3-8f85c65fa2c74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-5245-32003785245326 in 1 BLISTER PACKHistorical
0378-5245-85003785245851 BLISTER PACK in 1 CARTON (0378-5245-85) / 6 TABLET, FILM COATED in 1 BLISTER PACK (0378-5245-32) 1 blister pack2015-11-100000-00-00NoNoCurrent