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United States · US · US:69547-627_e1bd0aff-d415-4118-8af7-87ce6dc54bd4
NARCAN
Orange BookUNIISPLATC A06AH04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerEmergent Devices Inc.
CountryUS (United States)
ATC codeA06AH04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1169547627022 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-02) / .1 mL in 1 VIAL, SINGLE-DOSE
- ndc1169547627051 CASE in 1 CARTON (69547-627-05) / 2 VIAL, SINGLE-DOSE in 1 CASE / .1 mL in 1 VIAL, SINGLE-DOSE
- ndc1169547627066 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-06) / .1 mL in 1 VIAL, SINGLE-DOSE
- ndc11695476272424 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-24) / .1 mL in 1 VIAL, SINGLE-DOSE
Annotations
UNII (FDA Substance ID)
F850569PQR
NALOXONE HYDROCHLORIDE
RxCUI 203192
Orange Book
N208411
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": "NASAL",
"spl_meta": {
"a0ebc83d-2892-40de-bc0a-775ce90b30db": {
"match": "brand_token",
"title": "NARCAN (NALOXONE HYDROCHLORIDE NASAL) SPRAY [EMERGENT DEVICES INC.]",
"spl_version": "2",
"published_date": "2026-04-27"
}
},
"productid": "69547-627_e1bd0aff-d415-4118-8af7-87ce6dc54bd4",
"productndc": "69547-627",
"dosage_form": "SPRAY",
"orange_book": {
"appl_no": "208411",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "4MG/SPRAY",
"product_no": "001",
"approval_date": "Nov 18, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "002",
"approval_date": "Jan 24, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "NALOXONE HYDROCHLORIDE",
"proprietary_name": "NARCAN",
"active_ingred_unit": "mg/.1mL",
"application_number": "NDA208411",
"marketing_category": "NDA",
"nonproprietary_name": "naloxone hydrochloride nasal",
"start_marketing_date": "20230828",
"active_numerator_strength": "4"
}Related drugs
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- GBNaloxone 400micrograms/1ml solution for injection ampoulesAlliance Healthcare (Distribution) Ltd
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