🇺🇸
United States · US · US:64950-345_df5aecd4-2175-4495-b6cc-13d69e718d09
Promethazine Hydrochloride and Phenylephrine Hydrochloride
Orange BookUNIISPLATC C01CA
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGenus Lifesciences Inc.
CountryUS (United States)
ATC codeC01CA
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116495034516473 mL in 1 BOTTLE, PLASTIC (64950-345-16)
Annotations
UNII (FDA Substance ID)
04JA59TNSJ
PHENYLEPHRINE HYDROCHLORIDE
RxCUI 8164
Orange Book
A040654
AA
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "04JA59TNSJ",
"rxcui": "8164",
"inchikey": "OCYSGIYOVXAGKQ-FVGYRXGTSA-N",
"display_name": "PHENYLEPHRINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d": {
"match": "brand_token",
"title": "PROMETHAZINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "19",
"published_date": "2026-05-25"
}
},
"productid": "64950-345_df5aecd4-2175-4495-b6cc-13d69e718d09",
"productndc": "64950-345",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "040654",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "5MG/5ML;6.25MG/5ML",
"product_no": "001",
"approval_date": "Dec 7, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE",
"proprietary_name": "Promethazine Hydrochloride and Phenylephrine Hydrochloride",
"active_ingred_unit": "mg/5mL; mg/5mL",
"application_number": "ANDA040654",
"marketing_category": "ANDA",
"nonproprietary_name": "promethazine hydrochloride and phenylephrine hydrochloride",
"start_marketing_date": "20240715",
"active_numerator_strength": "5; 6.25"
}Related drugs
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