FDA.reportPublic FDA data

Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution

Product NDC
70436-155
11-digit product format
704360155
Labeler code
70436
Product ID
70436-155_4aa2923b-2421-409b-bcc6-75dc0c318cbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
Dosage form
SOLUTION
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA040649
Marketing category
ANDA
Marketing start
2020-10-05
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
Active strength
15 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
2023-12-31
Current FDA listing
Historical FDA.report record

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
4f881de7-085a-407e-abc2-faa3c0127432Product name120170811
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
70436-155-412026-01-29C16284748780-11030e365-5fdf-111a-e063-dadaa90a10e2Promethazine DM Oral Solution
70436-155-422026-01-29C16284748780-11030e365-5fdf-111a-e063-dadaa90a10e2Promethazine DM Oral Solution
70436-155-412024-12-09C16284748780-11030e365-5fdf-111a-e063-dadaa90a10e2Promethazine DM Oral Solution
70436-155-422024-12-09C16284748780-11030e365-5fdf-111a-e063-dadaa90a10e2Promethazine DM Oral Solution
70436-155-412024-07-30C16284748780-11030e365-5fdf-111a-e063-dadaa90a10e2Promethazine DM Oral Solution
70436-155-422024-07-30C16284748780-11030e365-5fdf-111a-e063-dadaa90a10e2Promethazine DM Oral Solution
70436-155-412024-01-30C16284748780-11030e365-5fdf-111a-e063-dadaa90a10e2Promethazine DM Oral Solution
70436-155-422024-01-30C16284748780-11030e365-5fdf-111a-e063-dadaa90a10e2Promethazine DM Oral Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-155-41Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution118 mL in 1 BOTTLESOLUTION1184
70436-155-42Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution473 mL in 1 BOTTLESOLUTION4734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-155PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION SOLUTION [SLATE RUN PHARMACEUTICALS, LLC]4Legacy NDC, 2 package rows20241210_afb6f95d-2838-4566-88bd-844628d760b4.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 SolutionPSN88137097-16b3-44b7-8e1f-26a8242d81795
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD88137097-16b3-44b7-8e1f-26a8242d81795
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSY88137097-16b3-44b7-8e1f-26a8242d81795
991528promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSNafb6f95d-2838-4566-88bd-844628d760b44
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDafb6f95d-2838-4566-88bd-844628d760b44
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSYafb6f95d-2838-4566-88bd-844628d760b44
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
991528promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN0b7bfbab-decb-970c-e063-6394a90a50ef2
991528promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN9c3e0e87-b2f5-4a09-9db8-6d088d2a5f252
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD9c3e0e87-b2f5-4a09-9db8-6d088d2a5f252
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD0b7bfbab-decb-970c-e063-6394a90a50ef2
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSY9c3e0e87-b2f5-4a09-9db8-6d088d2a5f252
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSY0b7bfbab-decb-970c-e063-6394a90a50ef2
991528promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSN68a4c521-6db0-4e94-9906-96e96e2513011
991528promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral SolutionPSNcb36756d-4a5e-4857-9767-99a7473a38421
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCD68a4c521-6db0-4e94-9906-96e96e2513011
991528dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral SolutionSCDcb36756d-4a5e-4857-9767-99a7473a38421
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSY68a4c521-6db0-4e94-9906-96e96e2513011
991528dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral SolutionSYcb36756d-4a5e-4857-9767-99a7473a38421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70436-155-4170436015541118 mL in 1 BOTTLE (70436-155-41) 118 ml2020-10-050000-00-00NoNoCurrent
70436-155-4270436015542473 mL in 1 BOTTLE (70436-155-42) 473 ml2020-10-050000-00-00NoNoCurrent