FDA.reportPublic FDA data

Naloxone Hydrochloride

Product NDC
42291-493
Requested package NDC
42291-493-02
11-digit product format
422910493
Labeler code
42291
Product ID
42291-493_485f83f8-8404-eae8-e063-6294a90a3c33
Type
HUMAN OTC DRUG
Nonproprietary name
Naloxone Hydrochloride
Dosage form
SPRAY
Route
NASAL
Labeler
AvKARE
Application
ANDA217992
Marketing category
ANDA
Marketing start
2024-05-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217992-001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217992-001NALOXONE HYDROCHLORIDE4MG/SPRAYSPRAY, METERED / NASAL2024-04-23a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAvKARE1766a7f1-d301-945f-e063-6294a90ac6f42026-01-14WarningsExact identifier
application applno (ANDA): 217992
application number: ANDA217992
ndc (package): 42291-493-02
ndc (product): 42291-493
ndc11 (package): 42291049302
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEAmneal Pharmaceuticals NY LLC8091a73d-9ecd-4578-a57b-5d85a2c5a16a2025-12-09WarningsExact identifier
application applno (ANDA): 217992
application number: ANDA217992
Naloxone HydrochlorideNALOXONE HYDROCHLORIDECVS Pharmacy, Inc840e017d-0142-4d0e-a80e-327ac44bc0c52024-04-24WarningsExact identifier
application applno (ANDA): 217992
application number: ANDA217992
Naloxone HydrochlorideNALOXONE HYDROCHLORIDEWalgreen Co.3829826b-e48f-4e26-869f-6b9e4ee0a8402024-04-24WarningsExact identifier
application applno (ANDA): 217992
application number: ANDA217992
Naloxone HydrochlorideNALOXONEAmneal Pharmaceuticals NY LLC8779a073-dc6e-410a-9959-fd370f0079f92024-04-19WarningsExact identifier
application applno (ANDA): 217992
application number: ANDA217992

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F850569PQRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1725059Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1766a7f1-d301-945f-e063-6294a90ac6f4Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-493-01Naloxone Hydrochloride0.1 mL in 1 VIAL, SINGLE-DOSESPRAY0.12
42291-493-02Naloxone Hydrochloride2 in 1 CARTONSPRAY22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-493-01EA - Each42291-4930ded3426-e087-4e00-b429-4fb9596b5bc412024-06-10
42291-493-02EA - Each42291-4931dc1c004-af28-41ee-8a4b-3bd7b5b520c512024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-493NALOXONE HYDROCHLORIDE SPRAY [AVKARE]1Current NDC, 2 package rows20240502_1766a7f1-d301-945f-e063-6294a90ac6f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725059naloxone HCl 4 MG in 0.1 ML Nasal SprayPSN1766a7f1-d301-945f-e063-6294a90ac6f42
1725059naloxone hydrochloride 40 MG/ML Nasal SpraySCD1766a7f1-d301-945f-e063-6294a90ac6f42
1725059naloxone HCl 4 MG per 0.1 ML Nasal SpraySY1766a7f1-d301-945f-e063-6294a90ac6f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42291-493-02422910493022 VIAL, SINGLE-DOSE in 1 CARTON (42291-493-02) / .1 mL in 1 VIAL, SINGLE-DOSE (42291-493-01) 2024-05-01NoNoCurrent