meropenem

Generic: meropenem

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

Drug Facts

Product Profile

Brand Name meropenem
Generic Name meropenem
Labeler gland pharma limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

meropenem 1 g/30mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-147
Product ID 68083-147_3a747235-2a80-4d63-bbbf-d81538daf99a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206141
Listing Expiration 2026-12-31
Marketing Start 2017-04-28

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083147
Hyphenated Format 68083-147

Supplemental Identifiers

RxCUI
1722934 1722939
UPC
0368083147013 0368083146016
UNII
FV9J3JU8B1

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 meropenem (source: ndc)
Generic Name meropenem (source: ndc)
Application Number ANDA206141 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/30mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-147-10) / 30 mL in 1 VIAL
source: ndc

Packages (1)

68083-147-10 10 VIAL in 1 CARTON (68083-147-10) / 30 mL in 1 VIAL

Ingredients (1)

meropenem (1 g/30mL)

Linked Drug Pages (1)

Meropenem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3a747235-2a80-4d63-bbbf-d81538daf99a", "openfda": {"upc": ["0368083147013", "0368083146016"], "unii": ["FV9J3JU8B1"], "rxcui": ["1722934", "1722939"], "spl_set_id": ["4e4e2c0c-df54-4229-ab90-fa671ecedd57"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-147-10)  / 30 mL in 1 VIAL", "package_ndc": "68083-147-10", "marketing_start_date": "20170428"}], "brand_name": "Meropenem", "product_id": "68083-147_3a747235-2a80-4d63-bbbf-d81538daf99a", "dosage_form": "INJECTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "68083-147", "generic_name": "Meropenem", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Meropenem", "active_ingredients": [{"name": "MEROPENEM", "strength": "1 g/30mL"}], "application_number": "ANDA206141", "marketing_category": "ANDA", "marketing_start_date": "20170428", "listing_expiration_date": "20261231"}