FDA.reportPublic FDA data

Naloxone Hydrochloride

Product NDC
0093-2165
11-digit product format
000932165
Labeler code
0093
Product ID
0093-2165_f68e5624-94f3-4331-8db9-5affce1fb2f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
SPRAY, METERED
Route
NASAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA209522
Marketing category
ANDA
Marketing start
2021-12-22
Marketing end
2026-06-30
Substance
NALOXONE HYDROCHLORIDE
Active strength
4 mg/.1mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Naloxone Hydrochloride

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
0093-2165-19Naloxone Hydrochloride1 in 1 BLISTER PACKSPRAY, METERED16
0093-2165-19Naloxone Hydrochloride0.1 mL in 1 VIAL, SINGLE-DOSESPRAY, METERED0.16
0093-2165-68Naloxone Hydrochloride2 in 1 CARTONSPRAY, METERED26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-2165-19EA - Each0093-216554951785-8a3a-491d-a4f0-08ab5561607912022-01-06
0093-2165-68EA - Each0093-21650708edc5-ec50-4a87-ab26-72ee4904801512022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-2165NALOXONE HYDROCHLORIDE SPRAY, METERED [TEVA PHARMACEUTICALS USA, INC.]6Current NDC, Legacy NDC, 3 package rows20241001_4a72d8cf-3c24-47d8-94d1-4e175f2da264.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN4a72d8cf-3c24-47d8-94d1-4e175f2da2646
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD4a72d8cf-3c24-47d8-94d1-4e175f2da2646
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY4a72d8cf-3c24-47d8-94d1-4e175f2da2646
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN2fc0a205-6075-6253-e063-6294a90ad2df3
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD2fc0a205-6075-6253-e063-6294a90ad2df3
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY2fc0a205-6075-6253-e063-6294a90ad2df3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-2165-19000932165191 in 1 BLISTER PACKHistorical
0093-2165-68000932165682 BLISTER PACK in 1 CARTON (0093-2165-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0093-2165-19) / .1 mL in 1 VIAL, SINGLE-DOSE2 blister pack2021-12-222026-06-30NoNoCurrent