FDA.reportPublic FDA data

Promethazine Hydrochloride

Product NDC
50383-801
11-digit product format
503830801
Labeler code
50383
Product ID
50383-801_a3856e47-6212-4526-ae17-089fe6b44675
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA040026
Marketing category
ANDA
Marketing start
1998-09-25
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 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-801-042024-01-30C16284748780-1d6a99b39-635f-a426-e053-dadaa90af4c2PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP
50383-801-082024-01-30C16284748780-1d6a99b39-635f-a426-e053-dadaa90af4c2PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP
50383-801-162024-01-30C16284748780-1d6a99b39-635f-a426-e053-dadaa90af4c2PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP
50383-801-042022-02-01C16284748780-1d6a99b39-635f-a426-e053-dadaa90af4c2PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP
50383-801-082022-02-01C16284748780-1d6a99b39-635f-a426-e053-dadaa90af4c2PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP
50383-801-162022-02-01C16284748780-1d6a99b39-635f-a426-e053-dadaa90af4c2PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP
50383-801-042022-01-28C16284748780-1d6a99b39-635f-a426-e053-dadaa90af4c2PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP
50383-801-082022-01-28C16284748780-1d6a99b39-635f-a426-e053-dadaa90af4c2PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP
50383-801-162022-01-28C16284748780-1d6a99b39-635f-a426-e053-dadaa90af4c2PROMETHAZINE HYDROCHLORIDE ORAL SOLUTION USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-801-04Promethazine Hydrochloride118 mL in 1 BOTTLESOLUTION1189
50383-801-08Promethazine Hydrochloride237 mL in 1 BOTTLESOLUTION2379
50383-801-16Promethazine Hydrochloride473 mL in 1 BOTTLESOLUTION4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-801-16ML - Milliliter50383-801bcd81ec9-9c54-4dfc-86ed-46813686d0f712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SOLUTION [HI-TECH PHARMACAL CO., INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-801PROMETHAZINE HYDROCHLORIDE SOLUTION [AKORN]9Legacy NDC, 3 package rows20221015_bd8d1f9a-242c-440b-a5eb-a50f64a1c1d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNbd8d1f9a-242c-440b-a5eb-a50f64a1c1d99
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDbd8d1f9a-242c-440b-a5eb-a50f64a1c1d99
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSYbd8d1f9a-242c-440b-a5eb-a50f64a1c1d99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-801-0450383080104118 mL in 1 BOTTLE (50383-801-04) 118 ml1998-09-250000-00-00NoNoCurrent
50383-801-0850383080108237 mL in 1 BOTTLE (50383-801-08) 237 ml1998-09-250000-00-00NoNoCurrent
50383-801-1650383080116473 mL in 1 BOTTLE (50383-801-16) 473 ml1998-09-250000-00-00NoNoCurrent