Promethazine Hydrochloride

Product NDC
70518-3340
11-digit product format
705183340
Labeler code
70518
Product ID
70518-3340_d83cdf5b-e843-4460-e053-2995a90aa688
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA083312
Marketing category
ANDA
Marketing start
2022-01-24
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
25 mg/mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
R61ZEH7I1IPROMETHAZINE HYDROCHLORIDE58-33-3PROMETHAZINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3340-07051833400025 AMPULE in 1 CARTON (70518-3340-0) > 1 mL in 1 AMPULE25 ampule2022-01-240000-00-00NoNoCurrent