🇺🇸
United States · US · US:0641-6205_2f3fbff5-628a-49f6-9867-06c876742876
Naloxone Hydrochloride
Orange BookUNIISPLATC A06AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA06AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11064162051010 SYRINGE in 1 CARTON (0641-6205-10) / 2 mL in 1 SYRINGE (0641-6205-01)
Annotations
UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
A212300
APAP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "F850569PQR",
"rxcui": "203192",
"inchikey": "RGPDIGOSVORSAK-STHHAXOLSA-N",
"display_name": "NALOXONE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"spl_meta": {
"8535cc84-ad4a-4d67-8480-fb5a2e3406f8": {
"match": "brand_token",
"title": "NALOXONE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]",
"spl_version": "35",
"published_date": "2026-05-28"
}
},
"productid": "0641-6205_2f3fbff5-628a-49f6-9867-06c876742876",
"productndc": "0641-6205",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "212300",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "1MG/ML",
"product_no": "001",
"approval_date": "Jun 10, 2022"
},
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "0.4MG/ML",
"product_no": "002",
"approval_date": "Mar 7, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NALOXONE HYDROCHLORIDE",
"proprietary_name": "Naloxone Hydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA212300",
"marketing_category": "ANDA",
"nonproprietary_name": "Naloxone Hydrochloride",
"start_marketing_date": "20220610",
"active_numerator_strength": "1"
}Related drugs
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- GBNaloxone 2mg/2ml solution for injection pre-filled syringesA A H Pharmaceuticals Ltd
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