erythromycin

Generic: erythromycin

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name erythromycin
Generic Name erythromycin
Labeler asclemed usa, inc.
Dosage Form OINTMENT
Routes
OPHTHALMIC
Active Ingredients

erythromycin 5 mg/g

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-196
Product ID 76420-196_d1fbbd69-37b7-7ae4-e053-2a95a90a8398
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064067
Listing Expiration 2026-12-31
Marketing Start 1994-07-29

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 76420196
Hyphenated Format 76420-196

Supplemental Identifiers

RxCUI
310149
UNII
63937KV33D
NUI
N0000009982 N0000175877 N0000175935 M0028311

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 (source: ndc)
Generic Name erythromycin (source: ndc)
Application Number ANDA064067 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (76420-196-03) / 3.5 g in 1 TUBE
source: ndc

Packages (1)

76420-196-03 1 TUBE in 1 CARTON (76420-196-03) / 3.5 g in 1 TUBE

Ingredients (1)

erythromycin (5 mg/g)

Linked Drug Pages (1)

Erythromycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "d1fbbd69-37b7-7ae4-e053-2a95a90a8398", "openfda": {"nui": ["N0000009982", "N0000175877", "N0000175935", "M0028311"], "unii": ["63937KV33D"], "rxcui": ["310149"], "spl_set_id": ["7810e881-5130-4a94-b2e0-9f63f8a7a504"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_pe": ["Decreased Sebaceous Gland Activity [PE]"], "pharm_class_epc": ["Macrolide [EPC]", "Macrolide Antimicrobial [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (76420-196-03)  / 3.5 g in 1 TUBE", "package_ndc": "76420-196-03", "marketing_start_date": "20211130"}], "brand_name": "Erythromycin", "product_id": "76420-196_d1fbbd69-37b7-7ae4-e053-2a95a90a8398", "dosage_form": "OINTMENT", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Macrolide Antimicrobial [EPC]", "Macrolide [EPC]", "Macrolides [CS]"], "product_ndc": "76420-196", "generic_name": "Erythromycin", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erythromycin", "active_ingredients": [{"name": "ERYTHROMYCIN", "strength": "5 mg/g"}], "application_number": "ANDA064067", "marketing_category": "ANDA", "marketing_start_date": "19940729", "listing_expiration_date": "20261231"}