FDA.reportPublic FDA data

Amyl Nitrite

Product NDC
46414-2222
11-digit product format
464142222
Labeler code
46414
Product ID
46414-2222_eb6e373b-5b5d-46ea-90bd-f2dc8d813b13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amyl Nitrite
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
James Alexander Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1979-02-07
Substance
AMYL NITRITE
Active strength
.3 g/.3mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amyl Nitrite
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMYL NITRITE.3 g/.3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
22T8Z09XAKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
577307Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1b6e536-df5f-4f76-8e3c-6dc2f1e9975eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46414-2222-1Amyl Nitrite0.3 mL in 1 AMPULEINHALANT0.32
46414-2222-8Amyl Nitrite144 in 1 CARTONINHALANT1442

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46414-2222-1EA - Each46414-22221651021a-c3a3-4ef1-b02b-4b5fb3c1114f12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amyl NitriteACTIVE INGREDIENT22T8Z09XAKAMYL NITRITE INHALANT [JAMES ALEXANDER CORPORATION]1
Amyl NitriteACTIVE MOIETY22T8Z09XAKAMYL NITRITE INHALANT [JAMES ALEXANDER CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46414-2222AMYL NITRITE INHALANT [JAMES ALEXANDER CORPORATION]2Current NDC, Legacy NDC, 2 package rows20190208_c1b6e536-df5f-4f76-8e3c-6dc2f1e9975e.zip

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
Amyl NitriteAMYL NITRITEJames Alexander Corporationc1b6e536-df5f-4f76-8e3c-6dc2f1e9975e2019-02-05Warnings, Adverse reactionsExact identifier
ndc (product): 46414-2222

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577307amyl nitrite 0.3 ML Nasal InhalantPSNc1b6e536-df5f-4f76-8e3c-6dc2f1e9975e2
577307amyl nitrite 0.3 ML Nasal InhalantSCDc1b6e536-df5f-4f76-8e3c-6dc2f1e9975e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46414-2222-1464142222010.3 mL in 1 AMPULE0.3 mlHistorical
46414-2222-846414222208144 AMPULE in 1 CARTON (46414-2222-8) / .3 mL in 1 AMPULE (46414-2222-1) 144 ampule1979-02-070000-00-00NoNoCurrent