phenergan

Generic: promethazine hcl

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenergan
Generic Name promethazine hcl
Labeler direct_rx
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 12.5 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-402
Product ID 72189-402_4c4baadf-895a-bd8e-e063-6294a90ad228
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040596
Listing Expiration 2027-12-31
Marketing Start 2022-12-01

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189402
Hyphenated Format 72189-402

Supplemental Identifiers

UNII
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 phenergan (source: ndc)
Generic Name promethazine hcl (source: ndc)
Application Number ANDA040596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (72189-402-10)
  • 12 TABLET in 1 BOTTLE (72189-402-12)
  • 30 TABLET in 1 BOTTLE (72189-402-30)
source: ndc

Packages (3)

Ingredients (1)

promethazine hydrochloride (12.5 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4c4baadf-895a-bd8e-e063-6294a90ad228", "openfda": {"unii": ["R61ZEH7I1I"], "spl_set_id": ["eec705f7-123a-7926-e053-2a95a90af46d"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (72189-402-10)", "package_ndc": "72189-402-10", "marketing_start_date": "20221201"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (72189-402-12)", "package_ndc": "72189-402-12", "marketing_start_date": "20221201"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-402-30)", "package_ndc": "72189-402-30", "marketing_start_date": "20221201"}], "brand_name": "Phenergan", "product_id": "72189-402_4c4baadf-895a-bd8e-e063-6294a90ad228", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "72189-402", "generic_name": "Promethazine HCL", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenergan", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "12.5 mg/1"}], "application_number": "ANDA040596", "marketing_category": "ANDA", "marketing_start_date": "20221201", "listing_expiration_date": "20271231"}