PROMETHAZINE HYDROCHLORIDE

Product NDC
63629-9151
11-digit product format
636299151
Labeler code
63629
Product ID
63629-9151_3f7ea585-390d-4486-9bcb-3aaf6fd368ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROMETHAZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040891
Marketing category
ANDA
Marketing start
2009-03-13
Marketing end
0000-00-00
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
6 mg/5mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9151-1ML - Milliliter63629-9151affcdf07-2dfc-417f-a8b6-c59d118406a412022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9151PROMETHAZINE HYDROCHLORIDE (PROMETHAZINE HYDROCHLORIDE) SOLUTION [BRYANT RANCH PREPACK]104Legacy NDC20240809_7d3cecca-d7c1-402a-b708-90952bf76425.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9151-163629915101473 mL in 1 BOTTLE (63629-9151-1) 473 ml2022-01-260000-00-00NoNoCurrent