meropenem

Generic: meropenem

Labeler: brooks steriscience limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name meropenem
Generic Name meropenem
Labeler brooks steriscience limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

meropenem 1 g/20mL

Manufacturer
BROOKS STERISCIENCE LIMITED

Identifiers & Regulatory

Product NDC 81962-001
Product ID 81962-001_4caa1d3a-1dba-7392-e063-6294a90a0080
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216154
Listing Expiration 2027-12-31
Marketing Start 2023-05-31

Pharmacologic Class

Classes
carbapenems [cs] penem antibacterial [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81962001
Hyphenated Format 81962-001

Supplemental Identifiers

UPC
0381962000018 0381962001022
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 ANDA216154 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 g/20mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (81962-001-01) / 20 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (81962-001-02) / 20 mL in 1 VIAL
  • 25 VIAL in 1 CARTON (81962-001-03) / 20 mL in 1 VIAL
source: ndc

Packages (3)

81962-001-01 1 VIAL in 1 CARTON (81962-001-01) / 20 mL in 1 VIAL 81962-001-02 10 VIAL in 1 CARTON (81962-001-02) / 20 mL in 1 VIAL 81962-001-03 25 VIAL in 1 CARTON (81962-001-03) / 20 mL in 1 VIAL

Ingredients (1)

meropenem (1 g/20mL)

Linked Drug Pages (1)

Meropenem ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4caa1d3a-1dba-7392-e063-6294a90a0080", "openfda": {"upc": ["0381962000018", "0381962001022"], "unii": ["FV9J3JU8B1"], "spl_set_id": ["58e165b7-e230-4459-abf9-06d5ca1dd7b2"], "manufacturer_name": ["BROOKS STERISCIENCE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (81962-001-01)  / 20 mL in 1 VIAL", "package_ndc": "81962-001-01", "marketing_start_date": "20230531"}, {"sample": false, "description": "10 VIAL in 1 CARTON (81962-001-02)  / 20 mL in 1 VIAL", "package_ndc": "81962-001-02", "marketing_start_date": "20230531"}, {"sample": false, "description": "25 VIAL in 1 CARTON (81962-001-03)  / 20 mL in 1 VIAL", "package_ndc": "81962-001-03", "marketing_start_date": "20230531"}], "brand_name": "Meropenem", "product_id": "81962-001_4caa1d3a-1dba-7392-e063-6294a90a0080", "dosage_form": "INJECTION", "pharm_class": ["Carbapenems [CS]", "Penem Antibacterial [EPC]"], "product_ndc": "81962-001", "generic_name": "Meropenem", "labeler_name": "BROOKS STERISCIENCE LIMITED", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Meropenem", "active_ingredients": [{"name": "MEROPENEM", "strength": "1 g/20mL"}], "application_number": "ANDA216154", "marketing_category": "ANDA", "marketing_start_date": "20230531", "listing_expiration_date": "20271231"}