🇺🇸
United States · US · US:71335-2264_ea0ecfd4-85b2-47c8-8113-755d28555607
Cevimeline Hydrochloride
Orange BookUNIISPLATC N07AX03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN07AX03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11713352264130 CAPSULE in 1 BOTTLE (71335-2264-1)
- ndc11713352264260 CAPSULE in 1 BOTTLE (71335-2264-2)
- ndc11713352264390 CAPSULE in 1 BOTTLE (71335-2264-3)
Annotations
UNII (FDA Substance ID)
P81Q6V85NP
CEVIMELINE HYDROCHLORIDE
RxCUI 260036
Orange Book
A091591
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "P81Q6V85NP",
"rxcui": "260036",
"inchikey": "ZSTLCHCDLIUXJE-ZGBAEQJLSA-N;ZSTLCHCDLIUXJE-GMLJRNIPSA-N",
"display_name": "CEVIMELINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"bcaaec18-4ee1-4cfd-84da-8fe3b8c54fc4": {
"match": "brand_token",
"title": "CEVIMELINE HYDROCHLORIDE CAPSULE [ASCLEMED USA INC.]",
"spl_version": "1",
"published_date": "2026-05-21"
}
},
"productid": "71335-2264_ea0ecfd4-85b2-47c8-8113-755d28555607",
"productndc": "71335-2264",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "091591",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "30MG",
"product_no": "001",
"approval_date": "Jul 8, 2013"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CEVIMELINE HYDROCHLORIDE",
"proprietary_name": "Cevimeline Hydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA091591",
"marketing_category": "ANDA",
"nonproprietary_name": "Cevimeline Hydrochloride",
"start_marketing_date": "20130708",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code N07AX03.
- 🇺🇸CevimelineSun Pharmaceutical Industries, Inc.
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- 🇺🇸cevimeline hydrochlorideLupin Pharmaceuticals,Inc.
- 🇺🇸cevimeline hydrochlorideCosette Pharmaceuticals, Inc.
- 🇺🇸cevimeline hydrochlorideNovel Laboratories, Inc.
- 🇺🇸Cevimeline HydrochlorideBryant Ranch Prepack
- 🇺🇸Cevimeline HydrochlorideViona Pharmaceuticals Inc
- 🇺🇸Cevimeline HydrochlorideMacleods Pharmaceuticals Limited
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