ertapenem

Generic: ertapenem sodium

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ertapenem
Generic Name ertapenem sodium
Labeler endo usa, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ertapenem sodium 1 g/1

Manufacturer
ENDO USA, Inc.

Identifiers & Regulatory

Product NDC 42023-221
Product ID 42023-221_1a5504a5-8ab8-4dac-8772-68b2092a8c7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021337
Listing Expiration 2026-12-31
Marketing Start 2018-07-26

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42023221
Hyphenated Format 42023-221

Supplemental Identifiers

RxCUI
1734683
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 sodium (source: ndc)
Application Number NDA021337 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 PACKAGE (42023-221-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-01)
source: ndc

Packages (1)

42023-221-10 10 VIAL, SINGLE-DOSE in 1 PACKAGE (42023-221-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-01)

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": "1a5504a5-8ab8-4dac-8772-68b2092a8c7a", "openfda": {"unii": ["2T90KE67L0"], "rxcui": ["1734683"], "spl_set_id": ["657855f2-7c92-4aa8-9c3d-51d08e56a09a"], "manufacturer_name": ["ENDO USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (42023-221-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (42023-221-01)", "package_ndc": "42023-221-10", "marketing_start_date": "20180726"}], "brand_name": "ERTAPENEM", "product_id": "42023-221_1a5504a5-8ab8-4dac-8772-68b2092a8c7a", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "42023-221", "generic_name": "ertapenem sodium", "labeler_name": "ENDO USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ERTAPENEM", "active_ingredients": [{"name": "ERTAPENEM SODIUM", "strength": "1 g/1"}], "application_number": "NDA021337", "marketing_category": "NDA", "marketing_start_date": "20180726", "listing_expiration_date": "20261231"}