FDA.reportPublic FDA data

Naloxone Hydrochloride

Product NDC
0480-3478
11-digit product format
004803478
Labeler code
0480
Product ID
0480-3478_7545d296-ad3c-4be1-9913-73b4f870e90c
Type
HUMAN OTC DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA209522
Marketing category
ANDA
Marketing start
2024-09-23
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
Naloxone Hydrochloride
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
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
0480-3478-19Naloxone Hydrochloride0.1 mL in 1 VIAL, SINGLE-DOSESPRAY, METERED0.12
0480-3478-19Naloxone Hydrochloride1 in 1 BLISTER PACKSPRAY, METERED12
0480-3478-68Naloxone Hydrochloride2 in 1 CARTONSPRAY, METERED22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0480-3478-19EA - Each0480-3478bd5d2924-8bce-4a1b-8b91-4dcbed15639f12024-11-05
0480-3478-68EA - Each0480-347811bee6a5-c48d-4ea2-8482-1e62af8bf97e12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0480-3478NALOXONE HYDROCHLORIDE SPRAY, METERED [TEVA PHARMACEUTICALS, INC.]2Current NDC, 3 package rows20241009_3a73ee4b-c2a4-496f-be90-9f78c8046062.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN3a73ee4b-c2a4-496f-be90-9f78c80460622
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD3a73ee4b-c2a4-496f-be90-9f78c80460622
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY3a73ee4b-c2a4-496f-be90-9f78c80460622
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN7acf3bde-f858-4fbc-8a11-6741a3d27b8e1
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD7acf3bde-f858-4fbc-8a11-6741a3d27b8e1
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY7acf3bde-f858-4fbc-8a11-6741a3d27b8e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-3478-19004803478190.1 mL in 1 VIAL, SINGLE-DOSE0.1 mlHistorical
0480-3478-68004803478682 BLISTER PACK in 1 CARTON (0480-3478-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0480-3478-19) / .1 mL in 1 VIAL, SINGLE-DOSE2 blister pack2024-09-23NoNoHistorical