Ergomar

Product NDC
81279-104
11-digit product format
812790104
Labeler code
81279
Product ID
81279-104_2ef9fa55-cdc3-dc0a-e063-6394a90a0e5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ergotamine Tartrate
Dosage form
TABLET
Route
ORAL
Labeler
Pangea Pharmaceuticals LLC
Application
ANDA087693
Marketing category
ANDA
Marketing start
2025-02-03
Substance
ERGOTAMINE TARTRATE
Active strength
2 mg/1
Pharmacologic classes
Ergotamine Derivative [EPC], Ergotamines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ergomar
Brand name suffix
Sublingual
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ERGOTAMINE TARTRATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMRU5XH3B48
Rxcui1293862, 1293864

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
32fd258b-9140-42bc-be18-18756be615a0Product name120170614
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81279-104-03Ergomar Sublingual1 in 1 CARTONTABLET12
81279-104-03Ergomar Sublingual3 in 1 BLISTER PACKTABLET32
81279-104-20Ergomar Sublingual2 in 1 CARTONTABLET22
81279-104-20Ergomar Sublingual10 in 1 BLISTER PACKTABLET102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81279-104ERGOMAR SUBLINGUAL (ERGOTAMINE TARTRATE) TABLET [PANGEA PHARMACEUTICALS LLC]2Current NDC, 4 package rows20250227_a9582fdb-7ddd-4f69-aa7a-66247cdb8c92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293864Ergomar 2 MG Sublingual TabletPSNa9582fdb-7ddd-4f69-aa7a-66247cdb8c922
1293862ergotamine tartrate 2 MG Sublingual TabletPSNa9582fdb-7ddd-4f69-aa7a-66247cdb8c922
1293864ergotamine tartrate 2 MG Sublingual Tablet [Ergomar]SBDa9582fdb-7ddd-4f69-aa7a-66247cdb8c922
1293862ergotamine tartrate 2 MG Sublingual TabletSCDa9582fdb-7ddd-4f69-aa7a-66247cdb8c922
1293864Ergomar 2 MG Sublingual TabletSYa9582fdb-7ddd-4f69-aa7a-66247cdb8c922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81279-104-03812790104031 BLISTER PACK in 1 CARTON (81279-104-03) / 3 TABLET in 1 BLISTER PACK1 blister pack2025-02-03NoNoCurrent
81279-104-20812790104202 BLISTER PACK in 1 CARTON (81279-104-20) / 10 TABLET in 1 BLISTER PACK2 blister pack2025-02-03NoNoCurrent