promethazine hydrochloride and dextromethorphan hydrobromide oral solution

Generic: promethazine hydrochloride and dextromethorphan hydrobromide oral solution

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride and dextromethorphan hydrobromide oral solution
Generic Name promethazine hydrochloride and dextromethorphan hydrobromide oral solution
Labeler nucare pharmaceuticals,inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 15 mg/5mL, promethazine hydrochloride 6.25 mg/5mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3551
Product ID 68071-3551_2d3fb2d4-6352-3f26-e063-6294a90a0163
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040649
Listing Expiration 2026-12-31
Marketing Start 2020-10-05

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680713551
Hyphenated Format 68071-3551

Supplemental Identifiers

RxCUI
991528
UPC
0368071355147
UNII
9D2RTI9KYH R61ZEH7I1I

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name promethazine hydrochloride and dextromethorphan hydrobromide oral solution (source: ndc)
Generic Name promethazine hydrochloride and dextromethorphan hydrobromide oral solution (source: ndc)
Application Number ANDA040649 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/5mL
  • 6.25 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (68071-3551-4)
source: ndc

Packages (1)

68071-3551-4 118 mL in 1 BOTTLE (68071-3551-4)

Ingredients (2)

dextromethorphan hydrobromide (15 mg/5mL) promethazine hydrochloride (6.25 mg/5mL)

Linked Drug Pages (1)

Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d3fb2d4-6352-3f26-e063-6294a90a0163", "openfda": {"upc": ["0368071355147"], "unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["0b7bfbab-decb-970c-e063-6394a90a50ef"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (68071-3551-4)", "package_ndc": "68071-3551-4", "marketing_start_date": "20231201"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "product_id": "68071-3551_2d3fb2d4-6352-3f26-e063-6294a90a0163", "dosage_form": "SOLUTION", "pharm_class": ["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]"], "product_ndc": "68071-3551", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "labeler_name": "NuCare Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA040649", "marketing_category": "ANDA", "marketing_start_date": "20201005", "listing_expiration_date": "20261231"}