NARCAN NALOXONE HCI

Product NDC
51662-1240
11-digit product format
516621240
Labeler code
51662
Product ID
51662-1240_07627f49-62b7-7d91-e063-6294a90a796d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NARCAN NALOXONE HCI
Dosage form
SPRAY
Route
NASAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA208411
Marketing category
NDA
Marketing start
2018-10-15
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

Additional Listing Data#

Finished product
Yes
Brand name base
NARCAN NALOXONE HCI
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF850569PQR
Rxcui1725059

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
65a3bc34-04ff-4cf1-aad9-c7d92a062f6dProduct name120231003
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
4c23a34c-e8fc-424c-8fa0-ee064ba6eaefProduct name120170706
0b8c7273-1da3-495f-909a-7cf1e96d2361Product name120161212
3df867ed-9d48-45cf-bded-1394beaea0b1Product name320161206
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1240-1NARCAN NALOXONE HCI0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.17
51662-1240-2NARCAN NALOXONE HCI2 in 1 PACKAGESPRAY27
51662-1240-2NARCAN NALOXONE HCI0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1240NARCAN NALOXONE HCI SPRAY [HF ACQUISITION CO LLC, DBA HEALTHFIRST]7Current NDC, Legacy NDC, 3 package rows20231011_784a0e98-c2d6-f845-e053-2991aa0ac4b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51662-1240-151662124001.1 mL in 1 VIAL, SINGLE-DOSE (51662-1240-1) 2018-10-150000-00-00NoNoCurrent
51662-1240-2516621240022 VIAL, SINGLE-DOSE in 1 PACKAGE (51662-1240-2) / .1 mL in 1 VIAL, SINGLE-DOSE2018-10-150000-00-00NoNoCurrent