Promethazine Hydrochloride

Product NDC
0904-6461
11-digit product format
009046461
Labeler code
0904
Product ID
0904-6461_85e0d628-0315-4ea2-b604-2b86a31ac2ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA084176
Marketing category
ANDA
Marketing start
2015-03-15
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6461-61EA - Each0904-6461f3770780-7af8-4221-9fb9-a4239248e21c12015-04-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6461-6100904646161100 BLISTER PACK in 1 CARTON (0904-6461-61) > 1 TABLET in 1 BLISTER PACK100 blister pack2015-03-150000-00-00NoNoCurrent