Paricalcitol
NDC product · U.S. Food and Drug Administration (openFDA) · United States
-
Product NDC
49483-688 -
Package NDC
49483-688-03 -
Application number
ANDA204948 -
SPL ID
eed565d0-059d-eef6-e053-2a95a90ac962 -
SPL set ID
f593b575-7537-4531-87fc-c1b0814fd018 -
UNII
6702D36OG5 -
RxCUI
577315 -
RxCUI
577317 -
RxCUI
577324
What the source publishes
- Labeler
- TIME CAP LABORATORIES, INC
- Active ingredients
- Paricalcitol
- Form
- CAPSULE, LIQUID FILLED
- Routes
- ORAL
- Administrative status
- present-in-source-snapshot
- Marketing status
- ANDA
- Product type
- HUMAN PRESCRIPTION DRUG
- Prescription
- Prescription or restricted
Names this record is found by
Complete source data
{
"name": "Paricalcitol",
"splId": "eed565d0-059d-eef6-e053-2a95a90ac962",
"labels": [
{
"setId": "f593b575-7537-4531-87fc-c1b0814fd018",
"labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f593b575-7537-4531-87fc-c1b0814fd018",
"labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=f593b575-7537-4531-87fc-c1b0814fd018"
}
],
"routes": [
"ORAL"
],
"labeler": "TIME CAP LABORATORIES, INC",
"finished": true,
"packaging": [
{
"sample": false,
"description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (49483-688-03)",
"package_ndc": "49483-688-03",
"identifierStatus": "well-formed",
"marketing_start_date": "20170103"
}
],
"productId": "49483-688_eed565d0-059d-eef6-e053-2a95a90ac962",
"useDomain": "unknown",
"dosageForm": "CAPSULE, LIQUID FILLED",
"productNdc": "49483-688",
"deaSchedule": null,
"genericName": "Paricalcitol",
"productType": "HUMAN PRESCRIPTION DRUG",
"listingStatus": "present-in-source-snapshot",
"targetSpecies": [],
"approvalStatus": "not-established-by-ndc-listing",
"labelAssociation": "openFDA-harmonized-set-ids; not a product-level approval match",
"marketingEndDate": null,
"activeIngredients": [
{
"name": "PARICALCITOL",
"strength": "2 ug/1"
}
],
"applicationNumber": "ANDA204948",
"marketingCategory": "ANDA",
"stateRestrictions": {
"status": "not-collected",
"observations": []
},
"useDomainEvidence": {
"basis": "unreviewed",
"field": null,
"value": null,
"version": 1,
"sourceId": "us.fda.ndc"
},
"marketingStartDate": "20151230",
"targetSpeciesStatus": "not-reported",
"prescriptionCategory": "prescription-or-restricted",
"harmonizedIdentifiers": {
"nui": [
"M0007651",
"N0000175907",
"N0000175849"
],
"upc": [
"0349483687033",
"0349483688030",
"0349483689037"
],
"unii": [
"6702D36OG5"
],
"rxcui": [
"577315",
"577317",
"577324"
],
"spl_set_id": [
"f593b575-7537-4531-87fc-c1b0814fd018"
],
"pharm_class_cs": [
"Ergocalciferols [CS]"
],
"pharm_class_epc": [
"Vitamin D2 Analog [EPC]",
"Vitamin D Analog [EPC]"
],
"manufacturer_name": [
"TIME CAP LABORATORIES, INC"
],
"is_original_packager": [
true
]
},
"listingExpirationDate": "20261231"
}
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