Dulera

Product NDC
0085-7206
11-digit product format
000857206
Labeler code
0085
Product ID
0085-7206_1ef5a40c-4197-4f13-aec6-51c20412bbad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mometasone furoate and formoterol fumarate dihydrate
Dosage form
AEROSOL
Route
RESPIRATORY (INHALATION)
Labeler
Merck Sharp & Dohme Corp.
Application
NDA022518
Marketing category
NDA
Marketing start
2010-06-22
Marketing end
0000-00-00
Substance
MOMETASONE FUROATE; FORMOTEROL FUMARATE
Active strength
100 ug/1; ug/1
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA],Adrenergic beta2-Agonists [MoA],beta2-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-7206-01GM - Gram0085-720632833158-7b11-445e-99ea-dcbda354848212012-07-24
0085-7206-07GM - Gram0085-72067bf9eccc-ee3a-402d-a16c-b5724bf76aee12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0085-7206-01000857206011 CANISTER in 1 CARTON (0085-7206-01) > 120 AEROSOL in 1 CANISTER1 canister2010-06-220000-00-00NoNoCurrent
0085-7206-02000857206021 CANISTER in 1 CARTON (0085-7206-02) > 120 AEROSOL in 1 CANISTER1 canister2010-06-220000-00-00NoNoCurrent
0085-7206-07000857206071 CANISTER in 1 CARTON (0085-7206-07) > 60 AEROSOL in 1 CANISTER1 canister2010-06-220000-00-00NoNoCurrent
0085-7206-08000857206081 CANISTER in 1 CARTON (0085-7206-08) > 60 AEROSOL in 1 CANISTER1 canister2010-06-220000-00-00NoNoCurrent