FDA.reportPublic FDA data

NARCAN

Product NDC
69547-627
11-digit product format
695470627
Labeler code
69547
Product ID
69547-627_e1bd0aff-d415-4118-8af7-87ce6dc54bd4
Type
HUMAN OTC DRUG
Nonproprietary name
naloxone hydrochloride nasal
Dosage form
SPRAY
Route
NASAL
Labeler
Emergent Devices Inc.
Application
NDA208411
Marketing category
NDA
Marketing start
2023-08-28
Substance
NALOXONE HYDROCHLORIDE
Active strength
4 mg/.1mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
NARCAN
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF850569PQR
Rxcui1725059, 1725064

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c955d208-c333-9bd7-be34-d7e12986d44eProduct name620250626
e5f98bfa-66d5-4c3a-b22d-9543d3bee304Product name120250204
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
69547-627-02NARCAN2 in 1 CARTONSPRAY22
69547-627-02NARCAN0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.12
69547-627-05NARCAN1 in 1 CARTONSPRAY12
69547-627-05NARCAN2 in 1 CASESPRAY22
69547-627-06NARCAN6 in 1 CARTONSPRAY62
69547-627-06NARCAN0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.12
69547-627-24NARCAN0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.12
69547-627-24NARCAN24 in 1 CARTONSPRAY242

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69547-627-02EA - Each69547-627e7bf7e0d-c9e9-49d7-b73c-40f32971920112023-09-05
69547-627-05EA - Each69547-6275d9ae8bb-b449-4cfb-97ec-99a01e6142a712026-05-22
69547-627-06EA - Each69547-6270f3a7443-1a41-47be-a4ac-a4939f79eddb12026-05-22
69547-627-24EA - Each69547-62764514733-44d0-433c-81b6-84c010e9932512026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69547-627NARCAN (NALOXONE HYDROCHLORIDE NASAL) SPRAY [EMERGENT DEVICES INC.]1Current NDC, 8 package rows20230828_a0ebc83d-2892-40de-bc0a-775ce90b30db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f922
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSNa0ebc83d-2892-40de-bc0a-775ce90b30db2
1725064NARCAN 4 MG in 0.1 ML Nasal SprayPSN3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f922
1725064NARCAN 4 MG in 0.1 ML Nasal SprayPSNa0ebc83d-2892-40de-bc0a-775ce90b30db2
1725064naloxone hydrochloride 40 MG/ML Nasal Spray [Narcan]SBD3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f922
1725064naloxone hydrochloride 40 MG/ML Nasal Spray [Narcan]SBDa0ebc83d-2892-40de-bc0a-775ce90b30db2
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f922
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCDa0ebc83d-2892-40de-bc0a-775ce90b30db2
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f922
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySYa0ebc83d-2892-40de-bc0a-775ce90b30db2
1725064Narcan 40 MG/ML Nasal SpraySY3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f922
1725064Narcan 40 MG/ML Nasal SpraySYa0ebc83d-2892-40de-bc0a-775ce90b30db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69547-627-02695470627022 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-02) / .1 mL in 1 VIAL, SINGLE-DOSE2023-08-28NoNoCurrent
69547-627-05695470627051 CASE in 1 CARTON (69547-627-05) / 2 VIAL, SINGLE-DOSE in 1 CASE / .1 mL in 1 VIAL, SINGLE-DOSE1 case2026-03-15NoNoCurrent
69547-627-06695470627066 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-06) / .1 mL in 1 VIAL, SINGLE-DOSE2026-03-15NoNoCurrent
69547-627-246954706272424 VIAL, SINGLE-DOSE in 1 CARTON (69547-627-24) / .1 mL in 1 VIAL, SINGLE-DOSE2026-03-15NoNoCurrent