Pomalidomide
NDC product · U.S. Food and Drug Administration (openFDA) · United States
-
Product NDC
70095-059 -
Package NDC
70095-059-01 -
Package NDC
70095-059-02 -
Application number
ANDA210232 -
SPL ID
5a6cdeaf-06a4-d9db-e063-6294a90a906e -
SPL set ID
3c222961-5398-4185-b2d0-defe90230094 -
UNII
D2UX06XLB5 -
RxCUI
1369718 -
RxCUI
1369726 -
RxCUI
1369730 -
RxCUI
1369734
What the source publishes
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Active ingredients
- Pomalidomide
- Form
- CAPSULE
- 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": "Pomalidomide",
"splId": "5a6cdeaf-06a4-d9db-e063-6294a90a906e",
"labels": [
{
"setId": "3c222961-5398-4185-b2d0-defe90230094",
"labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3c222961-5398-4185-b2d0-defe90230094",
"labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=3c222961-5398-4185-b2d0-defe90230094"
}
],
"routes": [
"ORAL"
],
"labeler": "Sun Pharmaceutical Industries, Inc.",
"finished": true,
"packaging": [
{
"sample": false,
"description": "21 CAPSULE in 1 BOTTLE (70095-059-01)",
"package_ndc": "70095-059-01",
"identifierStatus": "well-formed",
"marketing_start_date": "20260831"
},
{
"sample": false,
"description": "100 CAPSULE in 1 BOTTLE (70095-059-02)",
"package_ndc": "70095-059-02",
"identifierStatus": "well-formed",
"marketing_start_date": "20260831"
}
],
"productId": "70095-059_5a6cdeaf-06a4-d9db-e063-6294a90a906e",
"useDomain": "unknown",
"dosageForm": "CAPSULE",
"productNdc": "70095-059",
"deaSchedule": null,
"genericName": "Pomalidomide",
"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": "POMALIDOMIDE",
"strength": "3 mg/1"
}
],
"applicationNumber": "ANDA210232",
"marketingCategory": "ANDA",
"stateRestrictions": {
"status": "not-collected",
"observations": []
},
"useDomainEvidence": {
"basis": "unreviewed",
"field": null,
"value": null,
"version": 1,
"sourceId": "us.fda.ndc"
},
"marketingStartDate": "20260831",
"targetSpeciesStatus": "not-reported",
"prescriptionCategory": "prescription-or-restricted",
"harmonizedIdentifiers": {
"nui": [
"N0000184014"
],
"unii": [
"D2UX06XLB5"
],
"rxcui": [
"1369718",
"1369726",
"1369730",
"1369734"
],
"spl_set_id": [
"3c222961-5398-4185-b2d0-defe90230094"
],
"pharm_class_epc": [
"Thalidomide Analog [EPC]"
],
"manufacturer_name": [
"Sun Pharmaceutical Industries, Inc."
],
"is_original_packager": [
true
]
},
"listingExpirationDate": "20271231"
}
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