FDA.reportPublic FDA data

Promethazine Hydrochloride and Dextromethorphan Hydrobromide

Product NDC
62559-758
11-digit product format
625590758
Labeler code
62559
Product ID
62559-758_d9ff674c-ec90-4e98-9d7e-cfab92649343
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA011265
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-09-05
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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
3036445d-7d13-4411-a100-f2ac5ab8a276Product name120240110
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
2e7222fb-e3f1-febd-962f-ddbb495d6b5fProduct name220220126
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-758-04Promethazine Hydrochloride and Dextromethorphan Hydrobromide118 mL in 1 BOTTLESOLUTION1183
62559-758-16Promethazine Hydrochloride and Dextromethorphan Hydrobromide473 mL in 1 BOTTLESOLUTION4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-758-16ML - Milliliter62559-758fe7cb635-1880-4c76-be89-76f0c9be701012024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-758PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SOLUTION [ANI PHARMACEUTICALS, INC.]2Current NDC, 2 package rows20241030_a52e210f-b99d-493e-b679-ec565c6ff72d.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 SolutionPSNa52e210f-b99d-493e-b679-ec565c6ff72d3
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDa52e210f-b99d-493e-b679-ec565c6ff72d3
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSYa52e210f-b99d-493e-b679-ec565c6ff72d3
991528promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN702eb7c0-db4c-4729-b69e-99f64c63c7bd2
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD702eb7c0-db4c-4729-b69e-99f64c63c7bd2
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSY702eb7c0-db4c-4729-b69e-99f64c63c7bd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62559-758-0462559075804118 mL in 1 BOTTLE (62559-758-04) 118 ml2024-09-05NoNoHistorical
62559-758-1662559075816473 mL in 1 BOTTLE (62559-758-16) 473 ml2024-09-05NoNoHistorical