Promethazine Hydrochloride

Product NDC
0603-1584
11-digit product format
006031584
Labeler code
0603
Product ID
0603-1584_896908f5-e0f2-4ed0-8546-b24a0daef5aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA040643
Marketing category
ANDA
Marketing start
2006-04-26
Marketing end
2021-05-31
Substance
PROMETHAZINE HYDROCHLORIDE
Active strength
6 mg/5mL
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN92aaf002-fe5d-418d-8f57-000bdad8d4504
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD92aaf002-fe5d-418d-8f57-000bdad8d4504
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSY92aaf002-fe5d-418d-8f57-000bdad8d4504
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNe5be207b-122b-490f-a0d6-841132e451801
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDe5be207b-122b-490f-a0d6-841132e451801
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSYe5be207b-122b-490f-a0d6-841132e451801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-1584-5400603158454118 mL in 1 BOTTLE (0603-1584-54) 118 ml2006-04-262021-04-30NoNoCurrent
0603-1584-5800603158458473 mL in 1 BOTTLE (0603-1584-58) 473 ml2006-04-262021-05-31NoNoCurrent