FDA.reportPublic FDA data

Naloxone Hydrochloride

Product NDC
69238-2104
11-digit product format
692382104
Labeler code
69238
Product ID
69238-2104_102eb637-21d2-41bb-8ed9-0b0586bd1246
Type
HUMAN OTC DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA217992
Marketing category
ANDA
Marketing start
2024-04-24
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
Naloxone Hydrochloride
Listing expiration
2027-12-31

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-2104-1Naloxone Hydrochloride0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.111
69238-2104-7Naloxone Hydrochloride2 in 1 CARTONSPRAY211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-2104-1EA - Each69238-210491ff8fe2-0e79-477f-b698-28929742cf6512024-05-16
69238-2104-7EA - Each69238-210406b3edfc-7c4e-46db-a6cc-917639d8c9bf12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-2104NALOXONE HYDROCHLORIDE SPRAY [AMNEAL PHARMACEUTICALS NY LLC]8Current NDC, 2 package rows20240502_8091a73d-9ecd-4578-a57b-5d85a2c5a16a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN8091a73d-9ecd-4578-a57b-5d85a2c5a16a11
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD8091a73d-9ecd-4578-a57b-5d85a2c5a16a11
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY8091a73d-9ecd-4578-a57b-5d85a2c5a16a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69238-2104-1692382104010.1 mL in 1 VIAL, SINGLE-DOSE0.1 mlHistorical
69238-2104-7692382104072 VIAL, SINGLE-DOSE in 1 CARTON (69238-2104-7) / .1 mL in 1 VIAL, SINGLE-DOSE (69238-2104-1) 2024-04-24NoNoHistorical