🇺🇸
United States · US · US:47335-618_67134e3c-1819-4262-a36f-460afdbb165d
DRIZALMA SPRINKLE
Orange BookUNIISPLATC N06AX21
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSUN PHARMACEUTICAL INDUSTRIES, INC.
CountryUS (United States)
ATC codeN06AX21
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1147335618101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-618-10)
- ndc11473356183030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-618-30)
- ndc11473356186060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-618-60)
- ndc11473356189090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-618-90)
Annotations
UNII (FDA Substance ID)
9044SC542W
DULOXETINE HYDROCHLORIDE
RxCUI 476250
Orange Book
N212516
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "9044SC542W",
"rxcui": "476250",
"inchikey": "BFFSMCNJSOPUAY-LMOVPXPDSA-N",
"display_name": "DULOXETINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b41423b8-dfec-4d79-ba3c-e43a87803d85": {
"match": "brand_token",
"title": "DRIZALMA SPRINKLE (DULOXETINE) CAPSULE, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
"spl_version": "6",
"published_date": "2024-06-11"
}
},
"productid": "47335-618_67134e3c-1819-4262-a36f-460afdbb165d",
"productndc": "47335-618",
"dosage_form": "CAPSULE, DELAYED RELEASE",
"orange_book": {
"appl_no": "212516",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 20MG BASE",
"product_no": "001",
"approval_date": "Jul 19, 2019"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 30MG BASE",
"product_no": "002",
"approval_date": "Jul 19, 2019"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 40MG BASE",
"product_no": "003",
"approval_date": "Jul 19, 2019"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 60MG BASE",
"product_no": "004",
"approval_date": "Jul 19, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DULOXETINE HYDROCHLORIDE",
"proprietary_name": "DRIZALMA SPRINKLE",
"active_ingred_unit": "mg/1",
"application_number": "NDA212516",
"marketing_category": "NDA",
"nonproprietary_name": "Duloxetine",
"start_marketing_date": "20240610",
"active_numerator_strength": "40"
}Related drugs
Other records sharing ATC code N06AX21.
- CAACCEL-DULOXETINEACCEL PHARMA INC
- CAACCEL-DULOXETINEACCEL PHARMA INC
- CAAG-DULOXETINEANGITA PHARMA INC.
- CAAG-DULOXETINEANGITA PHARMA INC.
- 🇮🇹ALIKRES*28 cps gastroresistenti 30 mgC.T. LAB.FARMACEUTICO Srl
- 🇮🇹ALIKRES*28 cps gastroresistenti 60 mgC.T. LAB.FARMACEUTICO Srl
- CAAPO-DULOXETINEAPOTEX INC
- CAAPO-DULOXETINEAPOTEX INC
Access this data programmatically
Query DRIZALMA SPRINKLE 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.