ARFORMOTEROL TARTRATE

Product NDC
68462-833
11-digit product format
684620833
Labeler code
68462
Product ID
68462-833_d48b2582-5746-4cbd-9c9a-60e682e184e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
arformoterol tartrate
Dosage form
SOLUTION
Route
RESPIRATORY (INHALATION)
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA213132
Marketing category
ANDA
Marketing start
2021-06-22
Marketing end
2023-05-01
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-833-35ML - Milliliter68462-833e7d3497d-7245-4c99-87b3-c1f86610347312021-07-15
68462-833-65ML - Milliliter68462-833bc8b64a1-5483-48d3-90df-ef999fac429412021-07-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-833-306846208333030 POUCH in 1 CARTON (68462-833-30) > 1 VIAL in 1 POUCH > 2 mL in 1 VIAL30 pouch2021-06-220000-00-00NoNoCurrent
68462-833-35684620833356 POUCH in 1 CARTON (68462-833-35) > 5 VIAL in 1 POUCH > 2 mL in 1 VIAL6 pouch2021-06-220000-00-00NoNoCurrent
68462-833-606846208336015 POUCH in 1 CARTON (68462-833-60) > 4 VIAL in 1 POUCH > 2 mL in 1 VIAL15 pouch2021-06-220000-00-00NoNoCurrent
68462-833-656846208336512 POUCH in 1 CARTON (68462-833-65) > 5 VIAL in 1 POUCH > 2 mL in 1 VIAL12 pouch2021-06-220000-00-00NoNoCurrent