ertapenem

Generic: ertapenem sodium

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ertapenem
Generic Name ertapenem sodium
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ertapenem sodium 1 g/1

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-351
Product ID 68083-351_71422270-6a76-40e5-bd89-643b8b2fafd5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212040
Listing Expiration 2026-12-31
Marketing Start 2021-03-26

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083351
Hyphenated Format 68083-351

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 ANDA212040 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/1
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-351-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-351-01)
source: ndc

Packages (1)

68083-351-10 10 VIAL, SINGLE-DOSE in 1 CARTON (68083-351-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-351-01)

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": "71422270-6a76-40e5-bd89-643b8b2fafd5", "openfda": {"unii": ["2T90KE67L0"], "rxcui": ["1734683"], "spl_set_id": ["f74cca2f-e775-4580-acae-3a0c47dd24d9"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (68083-351-10)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (68083-351-01)", "package_ndc": "68083-351-10", "marketing_start_date": "20210326"}], "brand_name": "Ertapenem", "product_id": "68083-351_71422270-6a76-40e5-bd89-643b8b2fafd5", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "68083-351", "generic_name": "Ertapenem Sodium", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ertapenem", "active_ingredients": [{"name": "ERTAPENEM SODIUM", "strength": "1 g/1"}], "application_number": "ANDA212040", "marketing_category": "ANDA", "marketing_start_date": "20210326", "listing_expiration_date": "20261231"}