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United States · US · US:66993-495_0bc59709-3046-4364-b275-14464c1e9f8f
Teriparatide
Orange BookUNIISPLATC H05AA02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrasco Laboratories
CountryUS (United States)
ATC codeH05AA02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1166993495281 SYRINGE in 1 CARTON (66993-495-28) / 2.24 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
10T9CSU89I
TERIPARATIDE
RxCUI 32915
Orange Book
N021318
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": "66993-495_0bc59709-3046-4364-b275-14464c1e9f8f",
"productndc": "66993-495",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "021318",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.75MG/3ML (0.25MG/ML)",
"product_no": "001",
"approval_date": "Nov 26, 2002"
},
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "0.56MG/2.24ML (0.25MG/ML)",
"product_no": "002",
"approval_date": "Jun 25, 2008"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TERIPARATIDE",
"proprietary_name": "Teriparatide",
"active_ingred_unit": "ug/mL",
"application_number": "NDA021318",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Teriparatide",
"start_marketing_date": "20231117",
"active_numerator_strength": "250"
}Related drugs
Other records sharing ATC code H05AA02.
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