FDA.reportPublic FDA data

Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution

Product NDC
17856-0155
11-digit product format
178560155
Labeler code
17856
Product ID
17856-0155_35d2e40e-8eee-ef2d-e063-6294a90aadc0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA040649
Marketing category
ANDA
Marketing start
2020-10-05
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 Oral Solution
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0155-12025-03-28C16284748780-12cef2736-5eac-d83d-e063-dadaa90ab31fPromethazine DM Oral Solution
17856-0155-12025-01-30C16284748780-12cef2736-5eac-d83d-e063-dadaa90ab31fPromethazine DM Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0155-1Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution5 mL in 1 CUP, UNIT-DOSESOLUTION53
17856-0155-1Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution72 in 1 BOX, UNIT-DOSESOLUTION723

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0155PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION SOLUTION [ATLANTIC BIOLOGICALS CORP.]3Current NDC, 2 package rows20250525_3983d6d3-8bf4-4a88-962f-9bf72fd6e685.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 SolutionPSN3983d6d3-8bf4-4a88-962f-9bf72fd6e6853
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD3983d6d3-8bf4-4a88-962f-9bf72fd6e6853
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSY3983d6d3-8bf4-4a88-962f-9bf72fd6e6853

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
17856-0155-11785601550172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0155-1) / 5 mL in 1 CUP, UNIT-DOSE2023-09-13NoNoCurrent