erythromycin

Generic: erythromycin

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name erythromycin
Generic Name erythromycin
Labeler preferred pharmaceuticals inc.
Dosage Form OINTMENT
Routes
OPHTHALMIC
Active Ingredients

erythromycin 5 mg/g

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8516
Product ID 68788-8516_774d7de5-e3e2-4ec5-ba24-7033af9789a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062447
Listing Expiration 2026-12-31
Marketing Start 2023-09-01

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 687888516
Hyphenated Format 68788-8516

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 ANDA062447 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (68788-8516-3) / 3.5 g in 1 TUBE
source: ndc

Packages (1)

68788-8516-3 1 TUBE in 1 CARTON (68788-8516-3) / 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": "774d7de5-e3e2-4ec5-ba24-7033af9789a3", "openfda": {"nui": ["N0000009982", "N0000175877", "N0000175935", "M0028311"], "unii": ["63937KV33D"], "rxcui": ["310149"], "spl_set_id": ["093172ac-9e6b-4da7-8a14-42aa1aa4b3b3"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_pe": ["Decreased Sebaceous Gland Activity [PE]"], "pharm_class_epc": ["Macrolide [EPC]", "Macrolide Antimicrobial [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (68788-8516-3)  / 3.5 g in 1 TUBE", "package_ndc": "68788-8516-3", "marketing_start_date": "20230901"}], "brand_name": "erythromycin", "product_id": "68788-8516_774d7de5-e3e2-4ec5-ba24-7033af9789a3", "dosage_form": "OINTMENT", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Macrolide Antimicrobial [EPC]", "Macrolide [EPC]", "Macrolides [CS]"], "product_ndc": "68788-8516", "generic_name": "erythromycin", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "erythromycin", "active_ingredients": [{"name": "ERYTHROMYCIN", "strength": "5 mg/g"}], "application_number": "ANDA062447", "marketing_category": "ANDA", "marketing_start_date": "20230901", "listing_expiration_date": "20261231"}