betamethasone dipropionate

Generic: betamethasone dipropionate

Labeler: burel pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name betamethasone dipropionate
Generic Name betamethasone dipropionate
Labeler burel pharmaceuticals, llc
Dosage Form OINTMENT, AUGMENTED
Routes
TOPICAL
Active Ingredients

betamethasone dipropionate .5 mg/g

Manufacturer
Burel Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 35573-107
Product ID 35573-107_c8bda9a8-4dec-4084-84e5-4b4623390bd8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218289
Listing Expiration 2026-12-31
Marketing Start 2025-01-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 35573107
Hyphenated Format 35573-107

Supplemental Identifiers

RxCUI
848180
UPC
0335573107154 0335573107499
UNII
826Y60901U

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 dipropionate (source: ndc)
Generic Name betamethasone dipropionate (source: ndc)
Application Number ANDA218289 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (35573-107-15) / 15 g in 1 TUBE
  • 1 TUBE in 1 CARTON (35573-107-49) / 50 g in 1 TUBE
source: ndc

Packages (2)

35573-107-15 1 TUBE in 1 CARTON (35573-107-15) / 15 g in 1 TUBE 35573-107-49 1 TUBE in 1 CARTON (35573-107-49) / 50 g in 1 TUBE

Ingredients (1)

betamethasone dipropionate (.5 mg/g)

Linked Drug Pages (1)

BETAMETHASONE DIPROPIONATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "c8bda9a8-4dec-4084-84e5-4b4623390bd8", "openfda": {"upc": ["0335573107154", "0335573107499"], "unii": ["826Y60901U"], "rxcui": ["848180"], "spl_set_id": ["c8bda9a8-4dec-4084-84e5-4b4623390bd8"], "manufacturer_name": ["Burel Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (35573-107-15)  / 15 g in 1 TUBE", "package_ndc": "35573-107-15", "marketing_start_date": "20250115"}, {"sample": false, "description": "1 TUBE in 1 CARTON (35573-107-49)  / 50 g in 1 TUBE", "package_ndc": "35573-107-49", "marketing_start_date": "20250115"}], "brand_name": "BETAMETHASONE DIPROPIONATE", "product_id": "35573-107_c8bda9a8-4dec-4084-84e5-4b4623390bd8", "dosage_form": "OINTMENT, AUGMENTED", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "35573-107", "generic_name": "BETAMETHASONE DIPROPIONATE", "labeler_name": "Burel Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BETAMETHASONE DIPROPIONATE", "active_ingredients": [{"name": "BETAMETHASONE DIPROPIONATE", "strength": ".5 mg/g"}], "application_number": "ANDA218289", "marketing_category": "ANDA", "marketing_start_date": "20250115", "listing_expiration_date": "20261231"}