Promethazine VC

Product NDC
0121-0926
11-digit product format
001210926
Labeler code
0121
Product ID
0121-0926_bd449be1-5e7f-35a8-e053-2995a90a2e02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride and Phenylephrine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA040654
Marketing category
ANDA
Marketing start
2021-03-11
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
6 mg/5mL; mg/5mL
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS],alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0926-16ML - Milliliter0121-09268bf8ba20-b8a6-457e-8e99-e9e9a1f542a212021-04-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0926-1600121092616437 mL in 1 BOTTLE (0121-0926-16) 437 ml2021-03-110000-00-00NoNoCurrent