Promethazine Hydrochloride

Product NDC
21695-703
11-digit product format
216950703
Labeler code
21695
Product ID
21695-703_85f183af-6781-4ceb-9c21-c4ee9a06c355
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Rebel Distributors Corp
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
E
Listing certified through
2017-12-31
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-703-042019-09-24C16284748780-1934fe258-4b9c-48b1-e053-8cdaa90a720aPROMETHAZINE HYDROCHLORIDE SYRUP, USP 6.25 mg/5 mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-703-04Promethazine Hydrochloride118 mL in 1 BOTTLESYRUP1181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-703-04ML - Milliliter21695-70364868843-d1b0-46d7-892f-6195ed59345a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
ascorbic acidINACTIVE INGREDIENTPQ6CK8PD0RPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
sodium propionateINACTIVE INGREDIENTDK6Y9P42INPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
SUCROSEINACTIVE INGREDIENTC151H8M554PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-703PROMETHAZINE HYDROCHLORIDE SYRUP [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110113_85f183af-6781-4ceb-9c21-c4ee9a06c355.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsStatus
21695-703-0421695070304118 mL in 1 BOTTLE118 mlHistorical