teriparatide

Generic: teriparatide

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name teriparatide
Generic Name teriparatide
Labeler apotex corp.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

teriparatide 250 ug/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-6188
Product ID 60505-6188_8f15c891-ec65-6632-c161-e7bddfc3b3f2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211097
Listing Expiration 2026-12-31
Marketing Start 2023-11-16

Pharmacologic Class

Established (EPC)
parathyroid hormone analog [epc]
Chemical Structure
parathyroid hormone [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056188
Hyphenated Format 60505-6188

Supplemental Identifiers

RxCUI
1435115
UPC
0360505618804
UNII
10T9CSU89I
NUI
M0015931 N0000180852

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 teriparatide (source: ndc)
Generic Name teriparatide (source: ndc)
Application Number ANDA211097 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 250 ug/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (60505-6188-0) / 2.4 mL in 1 SYRINGE
source: ndc

Packages (1)

60505-6188-0 1 SYRINGE in 1 CARTON (60505-6188-0) / 2.4 mL in 1 SYRINGE

Ingredients (1)

teriparatide (250 ug/mL)

Linked Drug Pages (1)

Teriparatide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "8f15c891-ec65-6632-c161-e7bddfc3b3f2", "openfda": {"nui": ["M0015931", "N0000180852"], "upc": ["0360505618804"], "unii": ["10T9CSU89I"], "rxcui": ["1435115"], "spl_set_id": ["d77d40db-7f38-88eb-fd5d-4282f0642028"], "pharm_class_cs": ["Parathyroid Hormone [CS]"], "pharm_class_epc": ["Parathyroid Hormone Analog [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (60505-6188-0)  / 2.4 mL in 1 SYRINGE", "package_ndc": "60505-6188-0", "marketing_start_date": "20231117"}], "brand_name": "Teriparatide", "product_id": "60505-6188_8f15c891-ec65-6632-c161-e7bddfc3b3f2", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Parathyroid Hormone Analog [EPC]", "Parathyroid Hormone [CS]"], "product_ndc": "60505-6188", "generic_name": "Teriparatide", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Teriparatide", "active_ingredients": [{"name": "TERIPARATIDE", "strength": "250 ug/mL"}], "application_number": "ANDA211097", "marketing_category": "ANDA", "marketing_start_date": "20231116", "listing_expiration_date": "20261231"}