betamethasone sodium phosphate and betamethasone acetate

Generic: betamethasone sodium phosphate and betamethasone acetate

Labeler: american regent, 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 american regent, inc.
Dosage Form INJECTION, SUSPENSION
Routes
INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR
Active Ingredients

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

Manufacturer
American Regent, Inc.

Identifiers & Regulatory

Product NDC 0517-0720
Product ID 0517-0720_873bd493-ff1c-4cbb-960a-b1e8d73ab366
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 05170720
Hyphenated Format 0517-0720

Supplemental Identifiers

RxCUI
578803
UNII
TI05AO53L7 7BK02SCL3W

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 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
  • 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0720-01) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0517-0720-01 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0720-01) / 5 mL in 1 VIAL, MULTI-DOSE

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": "873bd493-ff1c-4cbb-960a-b1e8d73ab366", "openfda": {"unii": ["TI05AO53L7", "7BK02SCL3W"], "rxcui": ["578803"], "spl_set_id": ["a363b861-4873-465e-8009-0e9690666224"], "manufacturer_name": ["American Regent, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (0517-0720-01)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0517-0720-01", "marketing_start_date": "20100428"}], "brand_name": "Betamethasone Sodium Phosphate and Betamethasone Acetate", "product_id": "0517-0720_873bd493-ff1c-4cbb-960a-b1e8d73ab366", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Corticosteroid [EPC]"], "product_ndc": "0517-0720", "generic_name": "Betamethasone Sodium Phosphate and Betamethasone Acetate", "labeler_name": "American Regent, 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"}