meropenem

Generic: meropenem

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name meropenem
Generic Name meropenem
Labeler bluepoint laboratories
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

meropenem 500 mg/20mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-323
Product ID 68001-323_45bbbbfc-a4d7-c7ed-e063-6294a90aca41
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205883
Listing Expiration 2026-12-31
Marketing Start 2017-04-30

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001323
Hyphenated Format 68001-323

Supplemental Identifiers

RxCUI
1722934 1722939
UPC
0368001323291 0368001324588
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 ANDA205883 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/20mL
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Meropenem for injection, USP (I.V.) is supplied in 20 mL and 30 mL injection vials containing sufficient meropenem to deliver 500 mg or 1 gram for intravenous administration, respectively. The dry powder should be stored at controlled room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. 500 mg Injection Vial (NDC 68001-323-29) [Cartons of 10 - NDC 68001-323-31] 1 gram Injection Vial (NDC 68001-324-58) [Cartons of 10 - NDC 68001-324-57]
  • Package/Label Display Panel Meropenem for Injection, USP (I.V.) 500mg per vial 500mg per vial label - Rev 03-17
  • Package/Label Display Panel Meropenem for Injection, USP (I.V.) 500mg per vial 10 vials per carton 500mg per vial - 10 vials per carton - Rev 03-17
  • Package/Label Display Panel Meropenem for Injection, USP (I.V.) 1g per vial 1g per vial label - Rev 03-17
  • Package/Label Display Panel Meropenem for Injection, USP (I.V.) 1g per vial 10 vials per carton 1g per vial - 10 vials per carton - Rev 03-17
source: label

Packages (0)

No package records.

Ingredients (1)

meropenem (500 mg/20mL)

Linked Drug Pages (1)

Meropenem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "45bbbbfc-a4d7-c7ed-e063-6294a90aca41", "openfda": {"upc": ["0368001323291", "0368001324588"], "unii": ["FV9J3JU8B1"], "rxcui": ["1722934", "1722939"], "spl_set_id": ["ca5f501c-6520-4d09-aae2-4f5db74d468f"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Meropenem", "product_id": "68001-323_45bbbbfc-a4d7-c7ed-e063-6294a90aca41", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "68001-323", "generic_name": "Meropenem", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Meropenem", "active_ingredients": [{"name": "MEROPENEM", "strength": "500 mg/20mL"}], "application_number": "ANDA205883", "marketing_category": "ANDA", "marketing_start_date": "20170430", "listing_expiration_date": "20261231"}