DIHYDROERGOTAMINE MESYLATE

Product NDC
70069-880
11-digit product format
700690880
Labeler code
70069
Product ID
70069-880_8d88a6e3-0b91-4414-acce-4de8bb371ac1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIHYDROERGOTAMINE MESYLATE
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Somerset Therapeutics, LLC
Application
ANDA215228
Marketing category
ANDA
Marketing start
2026-03-24
Substance
DIHYDROERGOTAMINE MESYLATE
Active strength
4 mg/mL
Pharmacologic classes
Ergotamine Derivative [EPC], Ergotamines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DIHYDROERGOTAMINE MESYLATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIHYDROERGOTAMINE MESYLATE4 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii81AXN7R2QT
Rxcui861668

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c9a995-456f-4920-9be6-19f388510405Product name120260303
0dc20644-8d0b-4adf-9269-872bb65fd7fbProduct name320251205
803e1b3a-35b6-0bc8-229b-d2f7e8a7ffd4Product name520250516
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2053edd2-6ad3-4897-ba63-817235bdab3cProduct name220220309
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-880-01DIHYDROERGOTAMINE MESYLATE1 mL in 1 VIALSPRAY, METERED11
70069-880-01DIHYDROERGOTAMINE MESYLATE1 in 1 CARTONSPRAY, METERED11
70069-880-08DIHYDROERGOTAMINE MESYLATE8 in 1 KITSPRAY, METERED81

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-880-01ML - Milliliter70069-880c7a134fb-2bb1-4b82-8a71-65b0c557550412026-05-22
70069-880-08ML - Milliliter70069-8803f82eee6-e815-42b9-9146-59e15dd8ce6112026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861668dihydroergotamine mesylate 4 MG/mL Metered Dose Nasal SprayPSNc8ffdc19-a90d-453c-b094-2347e116b4051
861668dihydroergotamine mesylate 0.5 MG/ACTUAT Metered Dose Nasal SpraySCDc8ffdc19-a90d-453c-b094-2347e116b4051
861668DHE Mesylate 0.5 MG/ACTUAT Metered Dose Nasal SpraySYc8ffdc19-a90d-453c-b094-2347e116b4051
861668dihydroergotamine mesylate 0.5 MG/ACTUAT (4 MG/ML) Metered Dose Nasal SpraySYc8ffdc19-a90d-453c-b094-2347e116b4051

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-880-01700690880011 mL in 1 VIAL1 mlHistorical
70069-880-08700690880088 CARTON in 1 KIT (70069-880-08) / 1 VIAL in 1 CARTON (70069-880-01) / 1 mL in 1 VIAL8 carton2026-03-24NoNoCurrent