FDA.reportPublic FDA data

Zurnai

Product NDC
59011-962
11-digit product format
590110962
Labeler code
59011
Product ID
59011-962_34c86c07-3873-4f16-ac8d-8284c68426c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
NALMEFENE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Knoa Pharma LLC
Application
NDA218590
Marketing category
NDA
Marketing start
2025-08-07
Substance
NALMEFENE HYDROCHLORIDE
Active strength
1.5 mg/.5mL
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 43.

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
N218590-001ZURNAI (AUTOINJECTOR)NALMEFENE HYDROCHLORIDEEQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2024-08-07

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N218590-001118575472039-11-05Drug product2024-09-05
N218590-001118651122039-11-05U-3630Drug product2024-09-05

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N218590-001NP2027-08-07

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
2026-09-14 22:38:342026-08N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2024-08-0784e616aacf4f…
2026-08-18 06:07:402026-07N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2024-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2024-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2024-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2024-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2024-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD2024-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2024-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2024-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2024-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2024-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2024-08-07d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218590-001ZURNAI (AUTOINJECTOR)EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)SOLUTION / INTRAMUSCULAR, SUBCUTANEOUSRLD, RS2024-08-07a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 4 · 159 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N218590-001118575472039-11-05Drug product2024-09-0584e616aacf4f…
2026-09-14 22:38:342026-08N218590-001118651122039-11-05U-3630Drug product2024-09-0584e616aacf4f…
2026-08-18 06:07:402026-07N218590-001118575472039-11-05Drug product2024-09-05caaa826d4ba7…
2026-08-18 06:07:402026-07N218590-001118651122039-11-05U-3630Drug product2024-09-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218590-001118575472039-11-05Drug product2024-09-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N218590-001118651122039-11-05U-3630Drug product2024-09-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218590-001118575472039-11-05Drug product2024-09-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218590-001118651122039-11-05U-3630Drug product2024-09-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N218590-001118575472039-11-05Drug product2024-09-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N218590-001118651122039-11-05U-3630Drug product2024-09-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001104785602026-01-24Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001114464412026-01-24Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-00185625642026-01-24Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-00191802592026-01-24Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-00195331022026-01-24Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-00196299592026-01-24Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-00180213352026-10-04Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001102791312031-07-31Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001103576092031-08-21Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001109058272031-08-21Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001114464402031-08-21Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-00184966192031-08-21Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-00193646102031-08-21Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-00193646112031-08-21Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-00194461952031-08-21Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001111856422031-08-28Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001108817982034-02-11Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001118134352035-02-25Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001111919082035-10-18Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001118575472039-11-05Drug product2024-09-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001118651122039-11-05U-3630Drug product2024-09-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218590-001104785602026-01-24Drug product2024-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218590-001114464412026-01-24Drug product2024-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218590-00185625642026-01-24Drug product2024-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218590-00191802592026-01-24Drug product2024-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218590-00195331022026-01-24Drug product2024-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218590-00196299592026-01-24Drug product2024-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218590-00180213352026-10-04Drug product2024-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218590-001102791312031-07-31Drug product2024-09-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218590-001103576092031-08-21Drug product2024-09-05b8a1b40f171c…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N218590-001NP2027-08-0784e616aacf4f…
2026-08-18 06:07:402026-07N218590-001NP2027-08-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N218590-001NP2027-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218590-001NP2027-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N218590-001NP2027-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218590-001NP2027-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N218590-001NP2027-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N218590-001NP2027-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N218590-001NP2027-08-072680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N218590-001NP2027-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N218590-001NP2027-08-07d06236e962d9…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218590-001NP2027-08-07a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Zurnai
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NALMEFENE HYDROCHLORIDE1.5 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K7K69QC05XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2720806Internal RxNorm lookup
2720812Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a59a5847-9fe4-4341-a203-be0a5e6d3e36Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e7798c38-a53e-489a-b98c-9f4b01c0aab9Product name220250731
437f042c-2a66-4faa-b06c-0be5226687faProduct name120250313
c8c002c1-b6e1-4b46-8d55-5530f0dfb1b4Product name120231013
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59011-962-01Zurnai1 in 1 CARTONINJECTION, SOLUTION17
59011-962-01Zurnai0.5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.57

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59011-962-01ML - Milliliter59011-962ab7de151-cae4-4b5f-ae26-b93661cec73612025-09-12

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZurnaiNALMEFENE HYDROCHLORIDEKnoa Pharma LLCa59a5847-9fe4-4341-a203-be0a5e6d3e362026-07-31Warnings, Adverse reactionsExact identifier
application applno (NDA): 218590
application number: NDA218590
ndc (product): 59011-962

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2720806nalmefene 1.5 MG in 0.5 ML Auto-InjectorPSNa59a5847-9fe4-4341-a203-be0a5e6d3e367
2720812Zurnai 1.5 MG in 0.5 ML Auto-InjectorPSNa59a5847-9fe4-4341-a203-be0a5e6d3e367
27208120.5 ML nalmefene 3 MG/ML Auto-Injector [Zurnai]SBDa59a5847-9fe4-4341-a203-be0a5e6d3e367
27208060.5 ML nalmefene 3 MG/ML Auto-InjectorSCDa59a5847-9fe4-4341-a203-be0a5e6d3e367
2720806nalmefene 1.5 MG (equivalent to nalmefene HCl 1.7 MG) per 0.5 ML Auto-InjectorSYa59a5847-9fe4-4341-a203-be0a5e6d3e367
2720806nalmefene 1.5 MG per 0.5 ML Auto-InjectorSYa59a5847-9fe4-4341-a203-be0a5e6d3e367
2720812Zurnai 1.5 MG per 0.5 ML Auto-InjectorSYa59a5847-9fe4-4341-a203-be0a5e6d3e367

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
59011-962-01590110962011 SYRINGE, GLASS in 1 CARTON (59011-962-01) / .5 mL in 1 SYRINGE, GLASS2025-08-07NoNoCurrent