FDA.reportPublic FDA data

NALOXONE HYDROCHLORIDE

Product NDC
0404-9773
Requested package NDC
0404-9773-01
11-digit product format
004049773
Labeler code
0404
Product ID
0404-9773_dfa64508-45a2-41b2-b20f-eccda5e05c29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naloxone hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Henry Schein, Inc.
Application
ANDA218404
Marketing category
ANDA
Marketing start
2025-10-28
Substance
NALOXONE HYDROCHLORIDE
Active strength
.4 mg/mL
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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
A218404-001NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2024-02-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A218404-001AP

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 22:54:322026-06A218404-001NALOXONE HYDROCHLORIDE0.4MG/MLINJECTABLE / INJECTIONAP2024-02-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A218404-001AP1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
naloxone hydrochlorideNALOXONE HYDROCHLORIDELifestar Pharma LLCaef6719c-cd71-46ee-b7b1-1806b939bf3e2026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218404
application number: ANDA218404
NALOXONE HYDROCHLORIDENALOXONE HYDROCHLORIDEHenry Schein, Inc.ddeebc32-9aab-4a2f-8c87-74335d17d5ef2025-10-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218404
application number: ANDA218404
ndc (package): 0404-9773-01
ndc (product): 0404-9773
ndc11 (package): 00404977301
naloxone hydrochlorideNALOXONE HYDROCHLORIDENorthStar RxLLCd4c44b74-4e36-4b63-80eb-64ce99ccb39f2025-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218404
application number: ANDA218404
naloxone hydrochlorideNALOXONE HYDROCHLORIDELifestar Pharma LLCef647e2a-84e7-4e3e-942a-b6fc250141b62024-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218404
application number: ANDA218404

Additional Listing Data#

Finished product
Yes
Brand name base
NALOXONE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALOXONE HYDROCHLORIDE.4 mg/mL

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
1659929Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ddeebc32-9aab-4a2f-8c87-74335d17d5efAvailable 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
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
0404-9773-01NALOXONE HYDROCHLORIDE1 in 1 BAGINJECTION, SOLUTION11
0404-9773-01NALOXONE HYDROCHLORIDE1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659929naloxone HCl 0.4 MG in 1 ML InjectionPSNddeebc32-9aab-4a2f-8c87-74335d17d5ef1
16599291 ML naloxone hydrochloride 0.4 MG/ML InjectionSCDddeebc32-9aab-4a2f-8c87-74335d17d5ef1
1659929naloxone HCl 0.4 MG per 1 ML InjectionSYddeebc32-9aab-4a2f-8c87-74335d17d5ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0404-9773-01004049773011 VIAL, SINGLE-DOSE in 1 BAG (0404-9773-01) / 1 mL in 1 VIAL, SINGLE-DOSE2025-10-28NoNoCurrent