teriparatide

Generic: teriparatide

Labeler: amphastar pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name teriparatide
Generic Name teriparatide
Labeler amphastar pharmaceuticals, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

teriparatide 250 ug/mL

Manufacturer
Amphastar Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0548-2311
Product ID 0548-2311_0fe663ce-2f30-4de1-b873-804b21779241
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213641
Listing Expiration 2026-12-31
Marketing Start 2025-12-22

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 05482311
Hyphenated Format 0548-2311

Supplemental Identifiers

RxCUI
1435115
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 ANDA213641 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 250 ug/mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (0548-2311-00) / 2.24 mL in 1 SYRINGE
source: ndc

Packages (1)

0548-2311-00 1 SYRINGE in 1 CARTON (0548-2311-00) / 2.24 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": "0fe663ce-2f30-4de1-b873-804b21779241", "openfda": {"nui": ["M0015931", "N0000180852"], "unii": ["10T9CSU89I"], "rxcui": ["1435115"], "spl_set_id": ["d38b470a-2e62-487b-b3e7-134d3d1958b5"], "pharm_class_cs": ["Parathyroid Hormone [CS]"], "pharm_class_epc": ["Parathyroid Hormone Analog [EPC]"], "manufacturer_name": ["Amphastar Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (0548-2311-00)  / 2.24 mL in 1 SYRINGE", "package_ndc": "0548-2311-00", "marketing_start_date": "20251222"}], "brand_name": "Teriparatide", "product_id": "0548-2311_0fe663ce-2f30-4de1-b873-804b21779241", "dosage_form": "INJECTION", "pharm_class": ["Parathyroid Hormone Analog [EPC]", "Parathyroid Hormone [CS]"], "product_ndc": "0548-2311", "generic_name": "Teriparatide", "labeler_name": "Amphastar Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Teriparatide", "active_ingredients": [{"name": "TERIPARATIDE", "strength": "250 ug/mL"}], "application_number": "ANDA213641", "marketing_category": "ANDA", "marketing_start_date": "20251222", "listing_expiration_date": "20261231"}