NALOXONE HYDROCHLORIDE

Product NDC
45802-811
11-digit product format
458020811
Labeler code
45802
Product ID
45802-811_29fa6170-7b01-48a2-9e55-e213325e2d25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA211951
Marketing category
ANDA
Marketing start
2022-06-21
Marketing end
0000-00-00
Substance
NALOXONE HYDROCHLORIDE
Active strength
4 mg/.1mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-811NALOXONE HYDROCHLORIDE SPRAY [PADAGIS ISRAEL PHARMACEUTICALS LTD]3Legacy NDC20241027_29fa6170-7b01-48a2-9e55-e213325e2d25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSNf8fcda15-8ba6-e66a-e053-6294a90a385c2
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCDf8fcda15-8ba6-e66a-e053-6294a90a385c2
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySYf8fcda15-8ba6-e66a-e053-6294a90a385c2
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN0b3b5214-6f91-4bba-82d6-d57b16845df51
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN1e04b8aa-2363-34cd-e063-6394a90aa3f51
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN8d529b4c-85fd-4e50-9443-9080825307bf1
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD0b3b5214-6f91-4bba-82d6-d57b16845df51
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD1e04b8aa-2363-34cd-e063-6394a90aa3f51
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD8d529b4c-85fd-4e50-9443-9080825307bf1
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY0b3b5214-6f91-4bba-82d6-d57b16845df51
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY1e04b8aa-2363-34cd-e063-6394a90aa3f51
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY8d529b4c-85fd-4e50-9443-9080825307bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45802-811-84458020811842 VIAL, SINGLE-DOSE in 1 CARTON (45802-811-84) > .1 mL in 1 VIAL, SINGLE-DOSE (45802-811-00) 2022-06-210000-00-00NoNoCurrent