betamethasone sodium phosphate and betamethasone acetate

Generic: betamethasone sodium phosphate and betamethasone acetate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name betamethasone sodium phosphate and betamethasone acetate
Generic Name betamethasone sodium phosphate and betamethasone acetate
Labeler asclemed usa, inc.
Dosage Form INJECTION, SUSPENSION
Routes
INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR
Active Ingredients

betamethasone acetate 3 mg/mL, betamethasone sodium phosphate 3 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-007
Product ID 76420-007_ead06a22-6d5a-f9bb-e053-2a95a90aa12a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090747
Listing Expiration 2026-12-31
Marketing Start 2010-04-28

Pharmacologic Class

Classes
corticosteroid hormone receptor agonists [moa] corticosteroid [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420007
Hyphenated Format 76420-007

Supplemental Identifiers

RxCUI
578803
UNII
TI05AO53L7 7BK02SCL3W

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 betamethasone sodium phosphate and betamethasone acetate (source: ndc)
Generic Name betamethasone sodium phosphate and betamethasone acetate (source: ndc)
Application Number ANDA090747 (source: ndc)
Routes
INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 VIAL, MULTI-DOSE (76420-007-05)
source: ndc

Packages (1)

76420-007-05 5 mL in 1 VIAL, MULTI-DOSE (76420-007-05)

Ingredients (2)

betamethasone acetate (3 mg/mL) betamethasone sodium phosphate (3 mg/mL)

Linked Drug Pages (1)

Betamethasone Sodium Phosphate and Betamethasone Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTICULAR", "INTRALESIONAL", "INTRAMUSCULAR"], "spl_id": "ead06a22-6d5a-f9bb-e053-2a95a90aa12a", "openfda": {"unii": ["TI05AO53L7", "7BK02SCL3W"], "rxcui": ["578803"], "spl_set_id": ["c0a09d83-2405-450b-9f35-803d12823213"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL, MULTI-DOSE (76420-007-05)", "package_ndc": "76420-007-05", "marketing_start_date": "20200116"}], "brand_name": "Betamethasone Sodium Phosphate and Betamethasone Acetate", "product_id": "76420-007_ead06a22-6d5a-f9bb-e053-2a95a90aa12a", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Corticosteroid [EPC]"], "product_ndc": "76420-007", "generic_name": "Betamethasone Sodium Phosphate and Betamethasone Acetate", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Betamethasone Sodium Phosphate and Betamethasone Acetate", "active_ingredients": [{"name": "BETAMETHASONE ACETATE", "strength": "3 mg/mL"}, {"name": "BETAMETHASONE SODIUM PHOSPHATE", "strength": "3 mg/mL"}], "application_number": "ANDA090747", "marketing_category": "ANDA", "marketing_start_date": "20100428", "listing_expiration_date": "20261231"}