Almotriptan Malate

Product NDC
0093-5261
11-digit product format
000935261
Labeler code
0093
Product ID
0093-5261_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
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALMOTRIPTAN MALATE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPJP312605E
Rxcui284204, 284205

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
0093-5261-19Almotriptan Malate1 in 1 BLISTER PACKTABLET, FILM COATED16
0093-5261-29Almotriptan Malate12 in 1 CARTONTABLET, FILM COATED126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5261-19EA - Each0093-52614de5f013-da16-4c9c-b9b9-c710790b3c2112015-08-04
0093-5261-29EA - Each0093-5261276d2b06-818c-4b4d-acdd-8a31a8a97ae312015-08-04

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
0093-5261ALMOTRIPTAN MALATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]6Current NDC, Legacy NDC, 2 package rows20200828_c41a4579-9db0-402b-81b1-0adf5b3978c3.zip

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
0093-5261-19000935261191 in 1 BLISTER PACKHistorical
0093-5261-290009352612912 BLISTER PACK in 1 CARTON (0093-5261-29) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0093-5261-19) 12 blister pack2015-07-070000-00-00NoNoCurrent