celestone soluspan

Generic: betamethasone acetate and betamethasone sodium phosphate

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name celestone soluspan
Generic Name betamethasone acetate and betamethasone sodium phosphate
Labeler organon llc
Dosage Form INJECTION, SUSPENSION
Routes
INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR SOFT TISSUE
Active Ingredients

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

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-118
Product ID 78206-118_1086d646-36dd-465c-ab6d-fc4e3b51115b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA014602
Listing Expiration 2027-12-31
Marketing Start 2021-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206118
Hyphenated Format 78206-118

Supplemental Identifiers

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 celestone soluspan (source: ndc)
Generic Name betamethasone acetate and betamethasone sodium phosphate (source: ndc)
Application Number NDA014602 (source: ndc)
Routes
INTRA-ARTICULAR INTRALESIONAL INTRAMUSCULAR SOFT TISSUE
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 BOX (78206-118-01) / 5 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

78206-118-01 1 VIAL, MULTI-DOSE in 1 BOX (78206-118-01) / 5 mL in 1 VIAL, MULTI-DOSE

Ingredients (2)

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

Linked Drug Pages (1)

CELESTONE SOLUSPAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRA-ARTICULAR", "INTRALESIONAL", "INTRAMUSCULAR", "SOFT TISSUE"], "spl_id": "1086d646-36dd-465c-ab6d-fc4e3b51115b", "openfda": {"unii": ["TI05AO53L7", "7BK02SCL3W"], "spl_set_id": ["bf78d1be-42d7-4837-92a5-49113a79278f"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BOX (78206-118-01)  / 5 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "78206-118-01", "marketing_start_date": "20210601"}], "brand_name": "CELESTONE SOLUSPAN", "product_id": "78206-118_1086d646-36dd-465c-ab6d-fc4e3b51115b", "dosage_form": "INJECTION, SUSPENSION", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]", "Corticosteroid [EPC]"], "product_ndc": "78206-118", "generic_name": "Betamethasone Acetate and Betamethasone Sodium Phosphate", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CELESTONE SOLUSPAN", "active_ingredients": [{"name": "BETAMETHASONE ACETATE", "strength": "3 mg/mL"}, {"name": "BETAMETHASONE SODIUM PHOSPHATE", "strength": "3 mg/mL"}], "application_number": "NDA014602", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20271231"}