ertapenem sodium

Generic: ertapenem

Labeler: dr.reddys laboratories inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

ertapenem sodium 1 g/1

Manufacturer
Dr.Reddys Laboratories Inc.,

Identifiers & Regulatory

Product NDC 43598-901
Product ID 43598-901_39078864-5998-878d-b70d-8f46a61bbf02
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212040
Listing Expiration 2026-12-31
Marketing Start 2021-04-29

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598901
Hyphenated Format 43598-901

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 sodium (source: ndc)
Generic Name ertapenem (source: ndc)
Application Number ANDA212040 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (43598-901-58) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (43598-901-11)
source: ndc

Packages (1)

43598-901-58 10 VIAL, SINGLE-DOSE in 1 CARTON (43598-901-58) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (43598-901-11)

Ingredients (1)

ertapenem sodium (1 g/1)

Linked Drug Pages (1)

ERTAPENEM SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "39078864-5998-878d-b70d-8f46a61bbf02", "openfda": {"unii": ["2T90KE67L0"], "rxcui": ["1734683"], "spl_set_id": ["32d9f095-ca39-7e22-6264-b54f2daaee57"], "manufacturer_name": ["Dr.Reddys Laboratories Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (43598-901-58)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (43598-901-11)", "package_ndc": "43598-901-58", "marketing_start_date": "20210429"}], "brand_name": "ERTAPENEM SODIUM", "product_id": "43598-901_39078864-5998-878d-b70d-8f46a61bbf02", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "43598-901", "generic_name": "Ertapenem", "labeler_name": "Dr.Reddys Laboratories Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ERTAPENEM SODIUM", "active_ingredients": [{"name": "ERTAPENEM SODIUM", "strength": "1 g/1"}], "application_number": "ANDA212040", "marketing_category": "ANDA", "marketing_start_date": "20210429", "listing_expiration_date": "20261231"}