promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: cranbury pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler cranbury pharmaceuticals, llc
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

promethazine hydrochloride 6.25 mg/5mL

Manufacturer
Cranbury Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 27808-051
Product ID 27808-051_f00d9daa-3d9f-4645-b4a2-ecef6f85bab2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091675
Marketing Start 2012-06-08
Marketing End 2027-03-01

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27808051
Hyphenated Format 27808-051

Supplemental Identifiers

RxCUI
992432
UNII
R61ZEH7I1I

Packaging Origin

Original Packager
true

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 (source: ndc)
Generic Name promethazine hydrochloride (source: ndc)
Application Number ANDA091675 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 6.25 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (27808-051-02)
source: ndc

Packages (1)

27808-051-02 473 mL in 1 BOTTLE (27808-051-02)

Ingredients (1)

promethazine hydrochloride (6.25 mg/5mL)

Linked Drug Pages (1)

promethazine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f00d9daa-3d9f-4645-b4a2-ecef6f85bab2", "openfda": {"unii": ["R61ZEH7I1I"], "rxcui": ["992432"], "spl_set_id": ["d32ea9db-11d4-400d-b7ef-dd0ec01b796d"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (27808-051-02)", "package_ndc": "27808-051-02", "marketing_end_date": "20270301", "marketing_start_date": "20210930"}], "brand_name": "promethazine hydrochloride", "product_id": "27808-051_f00d9daa-3d9f-4645-b4a2-ecef6f85bab2", "dosage_form": "SYRUP", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "27808-051", "generic_name": "promethazine hydrochloride", "labeler_name": "Cranbury Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "promethazine hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "6.25 mg/5mL"}], "application_number": "ANDA091675", "marketing_category": "ANDA", "marketing_end_date": "20270301", "marketing_start_date": "20120608"}