promethazine hydrochloride and dextromethorphan hydrobromide oral solution

Generic: promethazine hydrochloride and dextromethorphan hydrobromide oral solution

Labeler: atlantic biologicals corp.
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 atlantic biologicals corp.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0155
Product ID 17856-0155_35d2e40e-8eee-ef2d-e063-6294a90aadc0
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 178560155
Hyphenated Format 17856-0155

Supplemental Identifiers

RxCUI
991528
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
  • 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0155-1) / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (1)

17856-0155-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0155-1) / 5 mL in 1 CUP, UNIT-DOSE

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": "35d2e40e-8eee-ef2d-e063-6294a90aadc0", "openfda": {"unii": ["9D2RTI9KYH", "R61ZEH7I1I"], "rxcui": ["991528"], "spl_set_id": ["3983d6d3-8bf4-4a88-962f-9bf72fd6e685"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0155-1)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "17856-0155-1", "marketing_start_date": "20230913"}], "brand_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "product_id": "17856-0155_35d2e40e-8eee-ef2d-e063-6294a90aadc0", "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": "17856-0155", "generic_name": "Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "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"}