PROMETHAZINE HYDROCHLORIDE

Product NDC
63187-858
11-digit product format
631870858
Labeler code
63187
Product ID
63187-858_4db2af05-d01e-4ccc-8d4b-84651835db6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROMETHAZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Proficient Rx LP
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-858PROMETHAZINE HYDROCHLORIDE SOLUTION [PROFICIENT RX LP]3Legacy NDC20191113_7cecdf97-6685-4cf5-ad88-3442fb83d810.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-858-0463187085804118 mL in 1 BOTTLE (63187-858-04) 118 ml2017-06-010000-00-00NoNoCurrent