ertapenem

Generic: ertapenem

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ertapenem
Generic Name ertapenem
Labeler eugia us llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ertapenem sodium 1 g/1

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-282
Product ID 55150-282_250abb8f-6547-4f69-94c3-87917dc34240
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209133
Listing Expiration 2026-12-31
Marketing Start 2018-06-25

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150282
Hyphenated Format 55150-282

Supplemental Identifiers

RxCUI
1734683
UPC
0355150282203
UNII
2T90KE67L0

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 ertapenem (source: ndc)
Generic Name ertapenem (source: ndc)
Application Number ANDA209133 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-20) / 1 INJECTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-282-20 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-20) / 1 INJECTION in 1 VIAL, SINGLE-DOSE

Ingredients (1)

ertapenem sodium (1 g/1)

Linked Drug Pages (2)

Ertapenem ndc-match (0.9) Ertapenem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "250abb8f-6547-4f69-94c3-87917dc34240", "openfda": {"upc": ["0355150282203"], "unii": ["2T90KE67L0"], "rxcui": ["1734683"], "spl_set_id": ["f725a68c-31a2-482a-9744-19adc47506b5"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (55150-282-20)  / 1 INJECTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-282-20", "marketing_start_date": "20180625"}], "brand_name": "Ertapenem", "product_id": "55150-282_250abb8f-6547-4f69-94c3-87917dc34240", "dosage_form": "INJECTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "55150-282", "generic_name": "Ertapenem", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ertapenem", "active_ingredients": [{"name": "ERTAPENEM SODIUM", "strength": "1 g/1"}], "application_number": "ANDA209133", "marketing_category": "ANDA", "marketing_start_date": "20180625", "listing_expiration_date": "20261231"}