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United States · US · US:59651-381_7d11010e-cf0f-4315-aced-7927a486a1ef
Clomipramine Hydrochloride
Orange BookUNIISPLATC N06AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN06AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115965138101100 CAPSULE in 1 BOTTLE (59651-381-01)
- ndc11596513813030 CAPSULE in 1 BOTTLE (59651-381-30)
- ndc11596513819090 CAPSULE in 1 BOTTLE (59651-381-90)
Annotations
UNII (FDA Substance ID)
2LXW0L6GWJ
CLOMIPRAMINE HYDROCHLORIDE
RxCUI 81984
Orange Book
A216440
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2LXW0L6GWJ",
"rxcui": "81984",
"inchikey": "WIMWMKZEIBHDTH-UHFFFAOYSA-N",
"display_name": "CLOMIPRAMINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"c33d02b1-9a00-4b4a-8f8e-d2679c3838bc": {
"match": "brand_token",
"title": "CLOMIPRAMINE HCL POWDER [AX PHARMACEUTICAL CORP]",
"spl_version": "1",
"published_date": "2026-04-14"
}
},
"productid": "59651-381_7d11010e-cf0f-4315-aced-7927a486a1ef",
"productndc": "59651-381",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "216440",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "25MG",
"product_no": "001",
"approval_date": "Mar 20, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "002",
"approval_date": "Mar 20, 2023"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "75MG",
"product_no": "003",
"approval_date": "Mar 20, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CLOMIPRAMINE HYDROCHLORIDE",
"proprietary_name": "Clomipramine Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA216440",
"marketing_category": "ANDA",
"nonproprietary_name": "Clomipramine Hydrochloride",
"start_marketing_date": "20230320",
"active_numerator_strength": "25"
}Related drugs
Other records sharing ATC code N06AA04.
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