erythromycin topical solution 2% (71656-030)

Drug Facts

Product Profile

Brand Name erythromycin topical solution 2%

Generic Name erythromycin topical solution 2%

Labeler saptalis pharmaceuticals, llc llc

Dosage Form SOLUTION

Routes

TOPICAL

Active Ingredients

erythromycin 20 mg/mL

Manufacturer

Saptalis Pharmaceuticals, LLC LLC

Identifiers & Regulatory

Product NDC 71656-030

Product ID 71656-030_21b6729d-f82f-309a-e063-6394a90a8a36

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA062687

Listing Expiration 2026-12-31

Marketing Start 2024-08-14

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 71656030

Hyphenated Format 71656-030

Supplemental Identifiers

RxCUI

318202

UPC

0371656030605

UNII

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 topical solution 2% (source: ndc)

Generic Name erythromycin topical solution 2% (source: ndc)

Application Number ANDA062687 (source: ndc)

Routes

TOPICAL

source: ndc

Resolved Composition

Strengths

20 mg/mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (71656-030-60) / 60 mL in 1 BOTTLE

source: ndc

Packages (1)

71656-030-60 1 BOTTLE in 1 CARTON (71656-030-60) / 60 mL in 1 BOTTLE

Ingredients (1)

erythromycin (20 mg/mL)

Linked Drug Pages (1)

erythromycin topical solution 2% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["TOPICAL"], "spl_id": "21b6729d-f82f-309a-e063-6394a90a8a36", "openfda": {"nui": ["N0000009982", "N0000175877", "N0000175935", "M0028311"], "upc": ["0371656030605"], "unii": ["63937KV33D"], "rxcui": ["318202"], "spl_set_id": ["21b64a3f-2c95-1c1a-e063-6294a90a0ea0"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_pe": ["Decreased Sebaceous Gland Activity [PE]"], "pharm_class_epc": ["Macrolide [EPC]", "Macrolide Antimicrobial [EPC]"], "manufacturer_name": ["Saptalis Pharmaceuticals, LLC LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71656-030-60)  / 60 mL in 1 BOTTLE", "package_ndc": "71656-030-60", "marketing_start_date": "20240814"}], "brand_name": "erythromycin topical solution 2%", "product_id": "71656-030_21b6729d-f82f-309a-e063-6394a90a8a36", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Macrolide Antimicrobial [EPC]", "Macrolide [EPC]", "Macrolides [CS]"], "product_ndc": "71656-030", "generic_name": "erythromycin topical solution 2%", "labeler_name": "Saptalis Pharmaceuticals, LLC LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "erythromycin topical solution 2%", "active_ingredients": [{"name": "ERYTHROMYCIN", "strength": "20 mg/mL"}], "application_number": "ANDA062687", "marketing_category": "ANDA", "marketing_start_date": "20240814", "listing_expiration_date": "20261231"}