FDA.reportPublic FDA data

FORANE

Product NDC
10019-360
11-digit product format
100190360
Labeler code
10019
Product ID
10019-360_94e9746a-3202-4180-b5f7-e6882a2b3081
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
isoflurane
Dosage form
INHALANT
Route
RESPIRATORY (INHALATION)
Labeler
Baxter Healthcare Corporation
Application
NDA017624
Marketing category
NDA
Marketing start
1979-12-18
Substance
ISOFLURANE
Active strength
1 mL/mL
Pharmacologic classes
General Anesthesia [PE], General Anesthetic [EPC]
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
N017624-001FORANEISOFLURANE99.9%LIQUID / INHALATIONANRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N017624-001AN

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 22:54:322026-06N017624-001FORANE99.9%LIQUID / INHALATIONANRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N017624-001AN1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FORANEISOFLURANEBaxter Healthcare Corporation3d30eb8d-a62e-475f-926b-78ba63bee9c82024-12-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 017624
application number: NDA017624
ndc (product): 10019-360

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ISOFLURANE1 mL/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
CYS9AKD70PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
542347Internal RxNorm lookup
542358Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d30eb8d-a62e-475f-926b-78ba63bee9c8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac9629df-d32a-4233-ad61-63593097af8aProduct name120220516

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10019-360-40FORANE6 in 1 PACKAGEINHALANT614
10019-360-40FORANE100 mL in 1 BOTTLE, GLASSINHALANT10014
10019-360-60FORANE250 mL in 1 BOTTLE, GLASSINHALANT25014
10019-360-60FORANE6 in 1 PACKAGEINHALANT614

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10019-360-40ML - Milliliter10019-360124292cb-f9cf-4a81-8360-cfd5cd13600912012-07-24
10019-360-60ML - Milliliter10019-360d91cc76f-a835-454d-b37b-47b12fed0b1612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOFLURANEACTIVE INGREDIENTCYS9AKD70PFORANE (ISOFLURANE) INHALANT [BAXTER HEALTHCARE CORPORATION]2
ISOFLURANEACTIVE MOIETYCYS9AKD70PFORANE (ISOFLURANE) INHALANT [BAXTER HEALTHCARE CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10019-360FORANE (ISOFLURANE) INHALANT [BAXTER HEALTHCARE CORPORATION]13Current NDC, Legacy NDC, 4 package rows20250507_3d30eb8d-a62e-475f-926b-78ba63bee9c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
542358Forane 99.9 % Inhalation SolutionPSN3d30eb8d-a62e-475f-926b-78ba63bee9c814
542347isoflurane 99.9 % Inhalation SolutionPSN3d30eb8d-a62e-475f-926b-78ba63bee9c814
542358isoflurane 999 MG/ML Inhalation Solution [Forane]SBD3d30eb8d-a62e-475f-926b-78ba63bee9c814
542347isoflurane 999 MG/ML Inhalation SolutionSCD3d30eb8d-a62e-475f-926b-78ba63bee9c814
542358Forane 99.9 % Inhalation SolutionSY3d30eb8d-a62e-475f-926b-78ba63bee9c814
542358Forane 999 MG/ML Inhalation SolutionSY3d30eb8d-a62e-475f-926b-78ba63bee9c814
542347isoflurane 99.9 % Inhalation SolutionSY3d30eb8d-a62e-475f-926b-78ba63bee9c814

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10019-360-40100190360406 BOTTLE, GLASS in 1 PACKAGE (10019-360-40) / 100 mL in 1 BOTTLE, GLASS1979-12-180000-00-00NoNoCurrent
10019-360-60100190360606 BOTTLE, GLASS in 1 PACKAGE (10019-360-60) / 250 mL in 1 BOTTLE, GLASS1979-12-180000-00-00NoNoCurrent