Promethazine Hydrochloride

Product NDC
70518-0165
11-digit product format
705180165
Labeler code
70518
Product ID
70518-0165_df4ee183-36f4-0991-e053-2995a90a0393
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA091179
Marketing category
ANDA
Marketing start
2017-01-20
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0165-37051801650315 TABLET in 1 BOTTLE, PLASTIC (70518-0165-3) 15 tablet2018-04-120000-00-00NoNoCurrent