🇺🇸
United States · US · US:84571-140_4525b96b-5ab9-b8fd-e063-6294a90aa699
ZIMHI
Orange BookUNIISPLATC A06AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZMI Pharma Inc.
CountryUS (United States)
ATC codeA06AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1184571140022 CASE in 1 CARTON (84571-140-02) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE
- ndc1184571140111 CASE in 1 CARTON (84571-140-11) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE
Annotations
UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
N212854
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; SUBCUTANEOUS",
"spl_meta": {
"523c0909-bff6-4010-988a-53de18b7cb3f": {
"match": "brand_token",
"title": "ZIMHI (NALOXONE HYDROCHLORIDE) INJECTION, SOLUTION [ZMI PHARMA INC.]",
"spl_version": "3",
"published_date": "2025-12-05"
}
},
"productid": "84571-140_4525b96b-5ab9-b8fd-e063-6294a90aa699",
"productndc": "84571-140",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "212854",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5MG/0.5ML (5MG/0.5ML)",
"product_no": "001",
"approval_date": "Oct 15, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "NALOXONE HYDROCHLORIDE",
"proprietary_name": "ZIMHI",
"active_ingred_unit": "mg/.5mL",
"application_number": "NDA212854",
"marketing_category": "NDA",
"nonproprietary_name": "Naloxone Hydrochloride",
"start_marketing_date": "20220115",
"active_numerator_strength": "5"
}Related drugs
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- GBNaloxone 1.26mg/0.1ml nasal spray unit doseA A H Pharmaceuticals Ltd
- GBNaloxone 2mg/2ml solution for injection pre-filled syringesMartindale Pharmaceuticals Ltd
- GBNaloxone 2mg/2ml solution for injection pre-filled syringesA A H Pharmaceuticals Ltd
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