ertapenem

Generic: ertapenem sodium

Labeler: qilu antibiotics pharmaceutical co., ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ertapenem
Generic Name ertapenem sodium
Labeler qilu antibiotics pharmaceutical co., ltd.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ertapenem sodium 1 g/1

Manufacturer
Qilu Antibiotics Pharmaceutical Co., Ltd.

Identifiers & Regulatory

Product NDC 51810-504
Product ID 51810-504_495048da-42bf-465b-bea5-57455ae23197
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218067
Listing Expiration 2026-12-31
Marketing Start 2024-10-31

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51810504
Hyphenated Format 51810-504

Supplemental Identifiers

RxCUI
1734683
UPC
0351810504012
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 ANDA218067 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (51810-504-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (51810-504-01)
source: ndc

Packages (1)

51810-504-02 10 VIAL, SINGLE-DOSE in 1 CARTON (51810-504-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (51810-504-01)

Ingredients (1)

ertapenem sodium (1 g/1)

Linked Drug Pages (1)

Ertapenem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "495048da-42bf-465b-bea5-57455ae23197", "openfda": {"upc": ["0351810504012"], "unii": ["2T90KE67L0"], "rxcui": ["1734683"], "spl_set_id": ["44496f7c-8407-4765-9cd6-1daa619a6db6"], "manufacturer_name": ["Qilu Antibiotics Pharmaceutical Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (51810-504-02)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (51810-504-01)", "package_ndc": "51810-504-02", "marketing_start_date": "20241031"}], "brand_name": "Ertapenem", "product_id": "51810-504_495048da-42bf-465b-bea5-57455ae23197", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "51810-504", "generic_name": "ertapenem sodium", "labeler_name": "Qilu Antibiotics Pharmaceutical Co., Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ertapenem", "active_ingredients": [{"name": "ERTAPENEM SODIUM", "strength": "1 g/1"}], "application_number": "ANDA218067", "marketing_category": "ANDA", "marketing_start_date": "20241031", "listing_expiration_date": "20261231"}