Arformoterol tartrate

Product NDC
0093-5955
11-digit product format
000935955
Labeler code
0093
Product ID
0093-5955_98de9422-52ec-42d8-b4c4-f3ad3b11460f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Arformoterol tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA200293
Marketing category
ANDA
Marketing start
2021-12-06
Marketing end
0000-00-00
Substance
ARFORMOTEROL TARTRATE
Active strength
15 ug/2mL
Pharmacologic classes
Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5955-06ML - Milliliter0093-59552ee0509e-ae84-49e1-ad4e-7d8481fa840012022-01-06
0093-5955-11ML - Milliliter0093-5955a85eb0cc-669e-4dfd-b4ec-fc8d26996f7812022-01-06
0093-5955-19ML - Milliliter0093-59553f5301f3-c557-49c5-a70a-688d98eb336712025-05-14
0093-5955-45ML - Milliliter0093-59555b3abcae-b46b-4f74-b49c-5525c467561012022-01-06
0093-5955-56ML - Milliliter0093-5955ed0d6673-5693-488b-b6fc-1157d85fa67b12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5955ARFORMOTEROL TARTRATE SOLUTION [TEVA PHARMACEUTICALS USA, INC.]5Legacy NDC20220709_07210cd5-679f-4834-8b77-724583e4c9c8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-5955-060009359550612 POUCH in 1 CARTON (0093-5955-06) > 5 AMPULE in 1 POUCH (0093-5955-45) > 2 mL in 1 AMPULE (0093-5955-19) 12 pouch2021-12-060000-00-00NoNoCurrent
0093-5955-560009359555630 POUCH in 1 CARTON (0093-5955-56) > 1 AMPULE in 1 POUCH (0093-5955-11) > 2 mL in 1 AMPULE30 pouch2021-12-060000-00-00NoNoCurrent