FDA.reportPublic FDA data

Promethazine Hydrochloride and Phenylephrine Hydrochloride

Product NDC
64950-345
11-digit product format
649500345
Labeler code
64950
Product ID
64950-345_df5aecd4-2175-4495-b6cc-13d69e718d09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride and phenylephrine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Genus Lifesciences Inc.
Application
ANDA040654
Marketing category
ANDA
Marketing start
2024-07-15
Substance
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
Active strength
5; 6.25 mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Phenothiazine [EPC], Phenothiazines [CS], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Promethazine Hydrochloride and Phenylephrine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/5mL
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ, R61ZEH7I1I
Rxcui1248057

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
d51697af-7f97-0559-95d1-fe94f3f031d5Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64950-345-16Promethazine Hydrochloride and Phenylephrine Hydrochloride473 mL in 1 BOTTLE, PLASTICSOLUTION4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64950-345-16ML - Milliliter64950-345c8cfc248-516b-42f0-a668-a4825f79769212024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64950-345PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE SOLUTION [GENUS LIFESCIENCES INC.]1Current NDC, 1 package rows20240724_7f8ebc9c-c4e6-4344-95a5-ec25b8c99bc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248057phenylephrine HCl 5 MG / promethazine HCl 6.25 MG in 5 mL Oral SolutionPSN7f8ebc9c-c4e6-4344-95a5-ec25b8c99bc11
1248057phenylephrine hydrochloride 1 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD7f8ebc9c-c4e6-4344-95a5-ec25b8c99bc11
1248057phenylephrine hydrochloride 5 MG / promethazine hydrochloride 6.25 MG per 5 ML Oral SolutionSY7f8ebc9c-c4e6-4344-95a5-ec25b8c99bc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64950-345-1664950034516473 mL in 1 BOTTLE, PLASTIC (64950-345-16) 473 ml2024-07-15NoNoHistorical