Voriconazole

Product NDC
60687-273
11-digit product format
606870273
Labeler code
60687
Product ID
60687-273_3f173cc6-1846-9797-e063-6394a90ad8eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Voriconazole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203503
Marketing category
ANDA
Marketing start
2017-08-11
Marketing end
2026-12-31
Substance
VORICONAZOLE
Active strength
200 mg/1
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203503-001VORICONAZOLEVORICONAZOLE50MGTABLET / ORALAB2015-09-02
A203503-002VORICONAZOLEVORICONAZOLE200MGTABLET / ORALAB2015-09-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203503-001AB
A203503-002AB

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-02caaa826d4ba7…
2026-08-18 06:07:402026-07A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203503-001VORICONAZOLE50MGTABLET / ORALAB2015-09-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203503-002VORICONAZOLE200MGTABLET / ORALAB2015-09-02bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203503-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203503-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203503-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203503-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203503-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203503-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203503-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203503-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203503-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203503-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203503-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203503-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203503-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203503-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203503-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203503-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203503-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203503-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203503-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203503-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203503-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203503-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203503-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203503-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203503-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203503-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203503-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203503-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203503-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203503-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203503-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203503-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203503-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203503-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203503-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203503-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203503-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203503-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203503-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203503-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Voriconazole

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VORICONAZOLE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JFU09I87TRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349434Internal RxNorm lookup
349435Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8379ac92-53cd-46db-8642-017f11830a86Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1f86875f-c0c9-343f-b96c-14093866e7a9Product name920190409
591c07fa-4d24-4cb9-9efc-86997c696aa7Product name120170602

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-273-11Voriconazole1 in 1 BLISTER PACKTABLET, FILM COATED19
60687-273-21Voriconazole30 in 1 BOX, UNIT-DOSETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-273-11EA - Each60687-2739d37b425-42aa-49b1-ad08-267a5ee091b612017-09-11
60687-273-21EA - Each60687-273d4c7180f-6f7a-4f86-8d31-d803ff4fe6b912017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-273VORICONAZOLE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20240913_8379ac92-53cd-46db-8642-017f11830a86.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VoriconazoleVORICONAZOLEAmerican Health Packaging8379ac92-53cd-46db-8642-017f11830a862025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203503
application number: ANDA203503
ndc (product): 60687-273
voriconazoleVORICONAZOLEGlenmark Pharmaceuticals Inc., USA4cbac6ad-0faa-4181-a830-27a9f1536b7a2025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203503
application number: ANDA203503

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349434voriconazole 200 MG Oral TabletPSN8379ac92-53cd-46db-8642-017f11830a869
349435voriconazole 50 MG Oral TabletPSN8379ac92-53cd-46db-8642-017f11830a869
349434voriconazole 200 MG Oral TabletSCD8379ac92-53cd-46db-8642-017f11830a869
349435voriconazole 50 MG Oral TabletSCD8379ac92-53cd-46db-8642-017f11830a869

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-273-11606870273111 in 1 BLISTER PACKHistorical
60687-273-216068702732130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-273-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-273-11) 30 blister pack2017-08-112026-12-31NoNoCurrent