🇺🇸
United States · US · US:0548-2311_0fe663ce-2f30-4de1-b873-804b21779241
Teriparatide
Orange BookUNIISPLATC H05AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmphastar Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeH05AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1105482311001 SYRINGE in 1 CARTON (0548-2311-00) / 2.24 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
10T9CSU89I
TERIPARATIDE
RxCUI 32915
Orange Book
A213641
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "10T9CSU89I",
"rxcui": "32915",
"inchikey": null,
"display_name": "TERIPARATIDE",
"substance_type": "protein",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"9d3f65e2-e8f0-4d33-b79e-989013dd3ca3": {
"match": "brand_token",
"title": "TERIPARATIDE INJECTION [BLUEPOINT LABORATORIES]",
"spl_version": "1",
"published_date": "2026-03-20"
}
},
"productid": "0548-2311_0fe663ce-2f30-4de1-b873-804b21779241",
"productndc": "0548-2311",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "213641",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.56MG/2.24ML (0.25MG/ML)",
"product_no": "001",
"approval_date": "Dec 12, 2025"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TERIPARATIDE",
"proprietary_name": "Teriparatide",
"active_ingred_unit": "ug/mL",
"application_number": "ANDA213641",
"marketing_category": "ANDA",
"nonproprietary_name": "Teriparatide",
"start_marketing_date": "20251222",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code H05AA02.
Access this data programmatically
Query Teriparatide and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.