Almotriptan Malate

Product NDC
0093-5260
11-digit product format
000935260
Labeler code
0093
Product ID
0093-5260_3c9afddb-516b-43a3-9a28-9a3b3aca6340
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Almotriptan Malate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA078027
Marketing category
ANDA
Marketing start
2015-07-07
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
A078027-001ALMOTRIPTAN MALATEALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-07
A078027-002ALMOTRIPTAN MALATEALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078027-001AB
A078027-002AB

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 UTC2026-02A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078027-001ALMOTRIPTAN MALATEEQ 6.25MG BASETABLET / ORALAB2015-07-07782e0a99824c…
2021-12-28 21:50 UTC2021-12A078027-002ALMOTRIPTAN MALATEEQ 12.5MG BASETABLET / ORALAB2015-07-07782e0a99824c…

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 UTC2026-02A078027-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078027-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078027-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078027-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078027-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078027-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078027-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078027-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078027-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078027-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078027-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078027-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078027-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078027-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078027-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078027-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078027-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078027-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078027-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078027-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078027-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078027-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078027-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078027-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078027-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078027-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078027-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078027-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078027-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078027-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078027-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078027-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078027-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078027-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078027-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078027-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078027-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078027-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078027-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078027-002AB1782e0a99824c…

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
c41a4579-9db0-402b-81b1-0adf5b3978c3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30fbb296-209a-3489-3171-031dc496d974Product name520201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-5260-18Almotriptan Malate6 in 1 CARTONTABLET, FILM COATED66
0093-5260-19Almotriptan Malate1 in 1 BLISTER PACKTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5260-18EA - Each0093-52600753f015-ca2f-42cc-9b41-f16112bf20f312015-08-04
0093-5260-19EA - Each0093-5260c91042e5-64d6-44c2-bb88-133cd01579e212015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALMOTRIPTAN MALATEACTIVE INGREDIENTPJP312605EALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
ALMOTRIPTANACTIVE MOIETY1O4XL5SN61ALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82ALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
HYPROMELLOSE 2910 (50 MPA.S)INACTIVE INGREDIENT1IVH67816NALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6ALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5260ALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]6Current NDC, Legacy NDC, 2 package rows20200828_c41a4579-9db0-402b-81b1-0adf5b3978c3.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 MalateALMOTRIPTAN MALATETeva Pharmaceuticals USA, Inc.c41a4579-9db0-402b-81b1-0adf5b3978c32017-05-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078027
application number: ANDA078027
ndc (product): 0093-5260

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284205almotriptan malate 12.5 MG Oral TabletPSNc41a4579-9db0-402b-81b1-0adf5b3978c36
284204almotriptan malate 6.25 MG Oral TabletPSNc41a4579-9db0-402b-81b1-0adf5b3978c36
284205almotriptan 12.5 MG Oral TabletSCDc41a4579-9db0-402b-81b1-0adf5b3978c36
284204almotriptan 6.25 MG Oral TabletSCDc41a4579-9db0-402b-81b1-0adf5b3978c36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-5260-18000935260186 BLISTER PACK in 1 CARTON (0093-5260-18) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-5260-19) 6 blister pack2015-07-070000-00-00NoNoCurrent
0093-5260-19000935260191 in 1 BLISTER PACKHistorical