FDA.reportPublic FDA data

Narcan

Product NDC
69547-353
Requested package NDC
69547-353-02
11-digit product format
695470353
Labeler code
69547
Product ID
69547-353_4536fef4-e317-a7fd-e063-6294a90aa0e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Emergent Devices Inc.
Application
NDA208411
Marketing category
NDA
Marketing start
2017-01-24
Substance
NALOXONE HYDROCHLORIDE
Active strength
4 mg/.1mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69547-35369547-353-02DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208411-001NARCANNALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASALRLD, RS2015-11-18
N208411-002NARCANNALOXONE HYDROCHLORIDE2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD2017-01-24

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N208411-001NARCAN4MG/SPRAYSPRAY, METERED / NASALRLD, RS2015-11-18a50c72e98297…
2026-08-01 22:54:322026-06N208411-002NARCAN2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SPRAY, METERED / NASALRLD2017-01-24a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NARCANNALOXONE HYDROCHLORIDE NASALSportpharm LLC3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f922026-04-24WarningsExact identifier
application applno (NDA): 208411
application number: NDA208411
NARCANNALOXONE HYDROCHLORIDE NASALEmergent Devices Inc.a0ebc83d-2892-40de-bc0a-775ce90b30db2026-04-22WarningsExact identifier
application applno (NDA): 208411
application number: NDA208411
NarcanNALOXONE HYDROCHLORIDEEmergent Devices Inc.724df050-5332-4d0a-9a5f-17bf08a547e12025-12-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 208411
application number: NDA208411
ndc (package): 69547-353-02
ndc (product): 69547-353
ndc11 (package): 69547035302
Narcan Naloxone HCLNARCAN NALOXONE HCLHF Acquisition Co LLC, DBA HealthFirst11d770b8-b768-ba3d-e063-6394a90a61a62024-02-20WarningsExact identifier
application applno (NDA): 208411
application number: NDA208411
Naloxone HydrochlorideNALOXONE HYDROCHLORIDE NASALA-S Medication Solutions4517afa1-4b17-4a15-b91b-65b18bd0558f2023-11-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 208411
application number: NDA208411
NARCAN NALOXONE HCINARCAN NALOXONE HCIHF Acquisition Co LLC, DBA HealthFirst784a0e98-c2d6-f845-e053-2991aa0ac4b42023-10-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 208411
application number: NDA208411
NARCANNALOXONE HYDROCHLORIDEA-S Medication Solutions139c30b9-5600-48f5-8610-0cacd27823982023-09-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 208411
application number: NDA208411
NarcanNALOXONE HYDROCHLORIDEProficient Rx LP76b5a1ce-e601-457c-ab35-43533bba43942022-08-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 208411
application number: NDA208411

Additional Listing Data#

Finished product
Yes
Brand name base
Narcan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALOXONE HYDROCHLORIDE4 mg/.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F850569PQRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1725059Internal RxNorm lookup
1725064Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
724df050-5332-4d0a-9a5f-17bf08a547e1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c955d208-c333-9bd7-be34-d7e12986d44eProduct name620250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304Product name120250204
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
caa6391e-3db3-c912-335f-61b5fc00aa12Product name920240110
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
65a3bc34-04ff-4cf1-aad9-c7d92a062f6dProduct name120231003
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e951cdf3-f269-4d97-a7d5-c1c3d7283a7dProduct name320230313
ab841ac7-728a-4fc9-be0a-35b96cecbf39Product name420230306
f327b80c-8fa2-404b-838a-df3eec141cf2Product name120221212
d4aa2fcf-79c3-4b5f-a00e-1a8e26e00119Product name120220511
b871fccd-1de6-4c7f-b9e5-045304641ee6Product name820220118
43b1efe2-1425-4b3e-b3a2-57d40f8478b9Product name120211026
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69547-353-02Narcan2 in 1 PACKAGESPRAY224
69547-353-02Narcan0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.124

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69547-353-02EA - Each69547-353fd96af4f-48c4-4353-b62e-67285d6a56b012016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69547-353NARCAN (NALOXONE HYDROCHLORIDE) SPRAY NARCAN (NALOXONE HYDROCHLORIDE) SPRAY [EMERGENT DEVICES INC.]21Current NDC, Legacy NDC, 2 package rows20221206_724df050-5332-4d0a-9a5f-17bf08a547e1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN139c30b9-5600-48f5-8610-0cacd278239828
1725064NARCAN 4 MG in 0.1 ML Nasal SprayPSN139c30b9-5600-48f5-8610-0cacd278239828
1725064naloxone hydrochloride 40 MG/ML Nasal Spray [Narcan]SBD139c30b9-5600-48f5-8610-0cacd278239828
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD139c30b9-5600-48f5-8610-0cacd278239828
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY139c30b9-5600-48f5-8610-0cacd278239828
1725064Narcan 40 MG/ML Nasal SpraySY139c30b9-5600-48f5-8610-0cacd278239828
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN724df050-5332-4d0a-9a5f-17bf08a547e124
1725064NARCAN 4 MG in 0.1 ML Nasal SprayPSN724df050-5332-4d0a-9a5f-17bf08a547e124
1725064naloxone hydrochloride 40 MG/ML Nasal Spray [Narcan]SBD724df050-5332-4d0a-9a5f-17bf08a547e124
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD724df050-5332-4d0a-9a5f-17bf08a547e124
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY724df050-5332-4d0a-9a5f-17bf08a547e124
1725064Narcan 40 MG/ML Nasal SpraySY724df050-5332-4d0a-9a5f-17bf08a547e124
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN784a0e98-c2d6-f845-e053-2991aa0ac4b47
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD784a0e98-c2d6-f845-e053-2991aa0ac4b47
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY784a0e98-c2d6-f845-e053-2991aa0ac4b47
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN76b5a1ce-e601-457c-ab35-43533bba43942
1725064NARCAN 4 MG in 0.1 ML Nasal SprayPSN76b5a1ce-e601-457c-ab35-43533bba43942
1725064naloxone hydrochloride 40 MG/ML Nasal Spray [Narcan]SBD76b5a1ce-e601-457c-ab35-43533bba43942
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD76b5a1ce-e601-457c-ab35-43533bba43942
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY76b5a1ce-e601-457c-ab35-43533bba43942
1725064Narcan 40 MG/ML Nasal SpraySY76b5a1ce-e601-457c-ab35-43533bba43942
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN1fc091cf-a492-2750-e063-6294a90a0aa81
1725064NARCAN 4 MG in 0.1 ML Nasal SprayPSN1fc091cf-a492-2750-e063-6294a90a0aa81
1725064naloxone hydrochloride 40 MG/ML Nasal Spray [Narcan]SBD1fc091cf-a492-2750-e063-6294a90a0aa81
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD1fc091cf-a492-2750-e063-6294a90a0aa81
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY1fc091cf-a492-2750-e063-6294a90a0aa81
1725064Narcan 40 MG/ML Nasal SpraySY1fc091cf-a492-2750-e063-6294a90a0aa81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69547-353-02695470353022 VIAL, SINGLE-DOSE in 1 PACKAGE (69547-353-02) / .1 mL in 1 VIAL, SINGLE-DOSE2017-01-242026-05-31NoNoCurrent