FDA.reportPublic FDA data

Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Product NDC
50090-6467
11-digit product format
500906467
Labeler code
50090
Product ID
50090-6467_17cc096b-1c05-43c4-a4e7-68f633ca212a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
promethazine hydrochloride and dextromethorphan hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA088864
Marketing category
ANDA
Marketing start
1985-01-04
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Active strength
15; 6.25 mg/5mL; mg/5mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Dextromethorphan Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/5mL
PROMETHAZINE HYDROCHLORIDE6.25 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, R61ZEH7I1I
Rxcui991528

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6467-0Promethazine Hydrochloride and Dextromethorphan Hydrobromide473 mL in 1 BOTTLE, PLASTICSYRUP4732
50090-6467-1Promethazine Hydrochloride and Dextromethorphan Hydrobromide473 mL in 1 BOTTLE, PLASTICSYRUP4732

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6467-0ML - Milliliter50090-6467c50d6df0-9c91-409a-aaa6-9b4d46acc8e912023-08-08
50090-6467-1ML - Milliliter50090-646771e9a9e0-b0c9-4106-b854-bcb7e4d79e3f12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6467PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [A-S MEDICATION SOLUTIONS]2Current NDC, 2 package rows20230712_ee227c52-2cd8-4a06-a2de-a257f1f4732a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
991528promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSNee227c52-2cd8-4a06-a2de-a257f1f4732a2
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDee227c52-2cd8-4a06-a2de-a257f1f4732a2
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSYee227c52-2cd8-4a06-a2de-a257f1f4732a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6467-050090646700473 mL in 1 BOTTLE, PLASTIC (50090-6467-0) 473 ml2023-05-08NoNoCurrent
50090-6467-150090646701473 mL in 1 BOTTLE, PLASTIC (50090-6467-1) 473 ml2023-05-08NoNoCurrent