erythromycin

Generic: erythromycin

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name erythromycin
Generic Name erythromycin
Labeler torrent pharmaceuticals limited
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

erythromycin 500 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-588
Product ID 13668-588_8c400049-2b9b-476d-a993-06aa5d3beba9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211975
Listing Expiration 2026-12-31
Marketing Start 2021-07-26

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 13668588
Hyphenated Format 13668-588

Supplemental Identifiers

RxCUI
310155 310157 315090
UPC
0313668586015 0313668587012
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 (source: ndc)
Generic Name erythromycin (source: ndc)
Application Number ANDA211975 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-588-01)
  • 500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-588-05)
  • 30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-588-30)
source: ndc

Packages (3)

13668-588-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-588-01) 13668-588-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-588-05) 13668-588-30 30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-588-30)

Ingredients (1)

erythromycin (500 mg/1)

Linked Drug Pages (1)

ERYTHROMYCIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8c400049-2b9b-476d-a993-06aa5d3beba9", "openfda": {"nui": ["N0000009982", "N0000175877", "N0000175935", "M0028311"], "upc": ["0313668586015", "0313668587012"], "unii": ["63937KV33D"], "rxcui": ["310155", "310157", "315090"], "spl_set_id": ["66b0d891-8756-43d1-b046-6dba787dd96f"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_pe": ["Decreased Sebaceous Gland Activity [PE]"], "pharm_class_epc": ["Macrolide [EPC]", "Macrolide Antimicrobial [EPC]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-588-01)", "package_ndc": "13668-588-01", "marketing_start_date": "20210726"}, {"sample": false, "description": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-588-05)", "package_ndc": "13668-588-05", "marketing_start_date": "20210726"}, {"sample": false, "description": "30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-588-30)", "package_ndc": "13668-588-30", "marketing_start_date": "20210921"}], "brand_name": "ERYTHROMYCIN", "product_id": "13668-588_8c400049-2b9b-476d-a993-06aa5d3beba9", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Decreased Sebaceous Gland Activity [PE]", "Macrolide Antimicrobial [EPC]", "Macrolide [EPC]", "Macrolides [CS]"], "product_ndc": "13668-588", "generic_name": "ERYTHROMYCIN", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ERYTHROMYCIN", "active_ingredients": [{"name": "ERYTHROMYCIN", "strength": "500 mg/1"}], "application_number": "ANDA211975", "marketing_category": "ANDA", "marketing_start_date": "20210726", "listing_expiration_date": "20261231"}