PROMETHAZINE HYDROCHLORIDE

Product NDC
60432-608
11-digit product format
604320608
Labeler code
60432
Product ID
60432-608_365a7dfe-15d5-4b78-8d4d-5341ffeb7872
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA087953
Marketing category
ANDA
Marketing start
1982-11-15
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
60432-608-162025-12-12C16284748780-1f386c649-d7f4-0266-e053-dadaa90a7c1a3919fb0c-a0b6-470b-9ff2-63600bcbfbc9
60432-608-162023-01-30C16284748780-1f386c649-d7f4-0266-e053-dadaa90a7c1a3919fb0c-a0b6-470b-9ff2-63600bcbfbc9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-608-04ML - Milliliter60432-608fd51cd5b-22c5-4cb7-9fa4-9f67147df8da12012-07-24
60432-608-16ML - Milliliter60432-6087212e465-f5fa-4851-aa61-8e93656c290912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [ATLANTIC BIOLOGICALS CORPS]3
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]2
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
sodium propionateINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [PROFICIENT RX LP]1
waterINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-608PROMETHAZINE HYDROCHLORIDE SYRUP [MORTON GROVE PHARMACEUTICALS, INC.]5Legacy NDC20191106_3919fb0c-a0b6-470b-9ff2-63600bcbfbc9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNbbdbc61c-3923-4832-b0a5-c0365dd8f5f95
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDbbdbc61c-3923-4832-b0a5-c0365dd8f5f95
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSYbbdbc61c-3923-4832-b0a5-c0365dd8f5f95
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN0e8199de-86cb-4450-a118-96927c9d59bf2
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSNc53f033b-212a-4c12-b205-b17241d93d002
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD0e8199de-86cb-4450-a118-96927c9d59bf2
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDc53f033b-212a-4c12-b205-b17241d93d002
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSY0e8199de-86cb-4450-a118-96927c9d59bf2
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSYc53f033b-212a-4c12-b205-b17241d93d002
992432promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN85f183af-6781-4ceb-9c21-c4ee9a06c3551
992432promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD85f183af-6781-4ceb-9c21-c4ee9a06c3551
992432promethazine HCl 6.25 MG per 5 ML Oral SyrupSY85f183af-6781-4ceb-9c21-c4ee9a06c3551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-608-1660432060816473 mL in 1 BOTTLE, PLASTIC (60432-608-16) 473 ml1982-11-150000-00-00NoNoCurrent