promethazine hydrochloride

Generic: promethazine hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name promethazine hydrochloride
Generic Name promethazine hydrochloride
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

promethazine hydrochloride 25 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-658
Product ID 71205-658_f274f5be-72ff-42e5-a4ba-8d1d957375b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040596
Listing Expiration 2026-12-31
Marketing Start 2014-01-13

Pharmacologic Class

Classes
phenothiazine [epc] phenothiazines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205658
Hyphenated Format 71205-658

Supplemental Identifiers

RxCUI
992447
UPC
0371205658106
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 promethazine hydrochloride (source: ndc)
Generic Name promethazine hydrochloride (source: ndc)
Application Number ANDA040596 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BOTTLE (71205-658-10)
  • 12 TABLET in 1 BOTTLE (71205-658-12)
  • 20 TABLET in 1 BOTTLE (71205-658-20)
  • 30 TABLET in 1 BOTTLE (71205-658-30)
  • 60 TABLET in 1 BOTTLE (71205-658-60)
  • 90 TABLET in 1 BOTTLE (71205-658-90)
source: ndc

Packages (6)

71205-658-10 10 TABLET in 1 BOTTLE (71205-658-10) 71205-658-12 12 TABLET in 1 BOTTLE (71205-658-12) 71205-658-20 20 TABLET in 1 BOTTLE (71205-658-20) 71205-658-30 30 TABLET in 1 BOTTLE (71205-658-30) 71205-658-60 60 TABLET in 1 BOTTLE (71205-658-60) 71205-658-90 90 TABLET in 1 BOTTLE (71205-658-90)

Ingredients (1)

promethazine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Promethazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f274f5be-72ff-42e5-a4ba-8d1d957375b0", "openfda": {"upc": ["0371205658106"], "unii": ["R61ZEH7I1I"], "rxcui": ["992447"], "spl_set_id": ["59b906c6-2ccc-416e-b3ee-db09bf553146"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BOTTLE (71205-658-10)", "package_ndc": "71205-658-10", "marketing_start_date": "20220505"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (71205-658-12)", "package_ndc": "71205-658-12", "marketing_start_date": "20230104"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (71205-658-20)", "package_ndc": "71205-658-20", "marketing_start_date": "20220927"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71205-658-30)", "package_ndc": "71205-658-30", "marketing_start_date": "20220505"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-658-60)", "package_ndc": "71205-658-60", "marketing_start_date": "20220505"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-658-90)", "package_ndc": "71205-658-90", "marketing_start_date": "20220505"}], "brand_name": "Promethazine Hydrochloride", "product_id": "71205-658_f274f5be-72ff-42e5-a4ba-8d1d957375b0", "dosage_form": "TABLET", "pharm_class": ["Phenothiazine [EPC]", "Phenothiazines [CS]"], "product_ndc": "71205-658", "generic_name": "Promethazine Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Promethazine Hydrochloride", "active_ingredients": [{"name": "PROMETHAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA040596", "marketing_category": "ANDA", "marketing_start_date": "20140113", "listing_expiration_date": "20261231"}