promethazine hydrochloride and codeine phosphate

Generic: promethazine hydrochloride and codeine phosphate

Labeler: atlantic biologicals corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride and codeine phosphate
Generic Name promethazine hydrochloride and codeine phosphate
Labeler atlantic biologicals corp.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

codeine phosphate 10 mg/5mL, promethazine hydrochloride 6.25 mg/5mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0065
Product ID 17856-0065_36c12aae-7566-5b2d-e063-6294a90a0dd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200386
DEA Schedule cv
Listing Expiration 2026-12-31
Marketing Start 2018-03-12

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc] phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 178560065
Hyphenated Format 17856-0065

Supplemental Identifiers

RxCUI
991486
UNII
GSL05Y1MN6 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 codeine phosphate (source: ndc)
Generic Name promethazine hydrochloride and codeine phosphate (source: ndc)
Application Number ANDA200386 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 6.25 mg/5mL
source: ndc
Packaging
  • 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0065-1) / 5 mL in 1 CUP, UNIT-DOSE
  • 1 CUP, UNIT-DOSE in 1 BAG (17856-0065-2) / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (2)

17856-0065-1 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0065-1) / 5 mL in 1 CUP, UNIT-DOSE 17856-0065-2 1 CUP, UNIT-DOSE in 1 BAG (17856-0065-2) / 5 mL in 1 CUP, UNIT-DOSE

Ingredients (2)

codeine phosphate (10 mg/5mL) promethazine hydrochloride (6.25 mg/5mL)

Linked Drug Pages (1)

Promethazine Hydrochloride and Codeine Phosphate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "36c12aae-7566-5b2d-e063-6294a90a0dd1", "openfda": {"unii": ["GSL05Y1MN6", "R61ZEH7I1I"], "rxcui": ["991486"], "spl_set_id": ["f8fb13e3-bc09-4004-a911-a38b6bbb0058"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0065-1)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "17856-0065-1", "marketing_start_date": "20200807"}, {"sample": false, "description": "1 CUP, UNIT-DOSE in 1 BAG (17856-0065-2)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "17856-0065-2", "marketing_start_date": "20250604"}], "brand_name": "Promethazine Hydrochloride and Codeine Phosphate", "product_id": "17856-0065_36c12aae-7566-5b2d-e063-6294a90a0dd1", "dosage_form": "SOLUTION", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]", "Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "17856-0065", "dea_schedule": "CV", "generic_name": "Promethazine Hydrochloride and Codeine Phosphate", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride and Codeine Phosphate", "active_ingredients": [{"name": "CODEINE PHOSPHATE", "strength": "10 mg/5mL"}, {"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA200386", "marketing_category": "ANDA", "marketing_start_date": "20180312", "listing_expiration_date": "20261231"}