erythromycin and benzoyl peroxide

Generic: erythromycin and benzoyl peroxide

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name erythromycin and benzoyl peroxide
Generic Name erythromycin and benzoyl peroxide
Labeler rising pharma holdings, inc.
Dosage Form GEL
Routes
TOPICAL
Active Ingredients

benzoyl peroxide 50 mg/g, erythromycin 30 mg/g

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-328
Product ID 64980-328_8547932c-ed72-4e13-b8fe-2b78919399d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065385
Listing Expiration 2026-12-31
Marketing Start 2016-10-18

Pharmacologic Class

Established (EPC)
macrolide [epc] macrolide antimicrobial [epc]
Chemical Structure
macrolides [cs]
Physiologic Effect
decreased sebaceous gland activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64980328
Hyphenated Format 64980-328

Supplemental Identifiers

RxCUI
244374
UNII
W9WZN9A0GM 63937KV33D
NUI
N0000009982 N0000175877 N0000175935 M0028311

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 erythromycin and benzoyl peroxide (source: ndc)
Generic Name erythromycin and benzoyl peroxide (source: ndc)
Application Number ANDA065385 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
  • 30 mg/g
source: ndc
Packaging
  • 23.3 g in 1 JAR (64980-328-01)
  • 46.6 g in 1 JAR (64980-328-02)
source: ndc

Packages (2)

64980-328-01 23.3 g in 1 JAR (64980-328-01) 64980-328-02 46.6 g in 1 JAR (64980-328-02)

Ingredients (2)

benzoyl peroxide (50 mg/g) erythromycin (30 mg/g)

Linked Drug Pages (1)

Erythromycin and Benzoyl Peroxide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "8547932c-ed72-4e13-b8fe-2b78919399d5", "openfda": {"nui": ["N0000009982", "N0000175877", "N0000175935", "M0028311"], "unii": ["W9WZN9A0GM", "63937KV33D"], "rxcui": ["244374"], "spl_set_id": ["d449d7e2-5c25-406d-87ab-30809d292476"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_pe": ["Decreased Sebaceous Gland Activity [PE]"], "pharm_class_epc": ["Macrolide [EPC]", "Macrolide Antimicrobial [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "23.3 g in 1 JAR (64980-328-01)", "package_ndc": "64980-328-01", "marketing_start_date": "20161018"}, {"sample": false, "description": "46.6 g in 1 JAR (64980-328-02)", "package_ndc": "64980-328-02", "marketing_start_date": "20161018"}], "brand_name": "Erythromycin and Benzoyl Peroxide", "product_id": "64980-328_8547932c-ed72-4e13-b8fe-2b78919399d5", "dosage_form": "GEL", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Macrolide Antimicrobial [EPC]", "Macrolide [EPC]", "Macrolides [CS]"], "product_ndc": "64980-328", "generic_name": "Erythromycin and Benzoyl Peroxide", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erythromycin and Benzoyl Peroxide", "active_ingredients": [{"name": "BENZOYL PEROXIDE", "strength": "50 mg/g"}, {"name": "ERYTHROMYCIN", "strength": "30 mg/g"}], "application_number": "ANDA065385", "marketing_category": "ANDA", "marketing_start_date": "20161018", "listing_expiration_date": "20261231"}