FDA.reportPublic FDA data

Posaconazole

Product NDC
73141-023
Requested package NDC
73141-023-02
11-digit product format
731410023
Labeler code
73141
Product ID
73141-023_3249fa0e-2b53-ebfb-e063-6394a90a2d78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Posaconazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
A2A Integrated Pharmaceuticals
Application
ANDA216488
Marketing category
ANDA
Marketing start
2024-05-16
Substance
POSACONAZOLE
Active strength
100 mg/1
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
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
A216488-001POSACONAZOLEPOSACONAZOLE100MGTABLET, DELAYED RELEASE / ORALAB2023-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216488-001AB

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 22:54:322026-06A216488-001POSACONAZOLE100MGTABLET, DELAYED RELEASE / ORALAB2023-08-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A216488-001AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PosaconazolePOSACONAZOLEBryant Ranch Prepackf15fc7d4-04ea-4be5-bfed-9a8bae74591c2025-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216488
application number: ANDA216488
PosaconazolePOSACONAZOLEBryant Ranch Prepack42a53b61-be3b-4c69-a3df-d12401dbd0e42025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216488
application number: ANDA216488
PosaconazolePOSACONAZOLEA2A Integrated Pharmaceuticals4d14ceab-196e-4dc3-8b21-5c4629ada1612025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216488
application number: ANDA216488
ndc (package): 73141-023-02
ndc (product): 73141-023
ndc11 (package): 73141002302
PosaconazolePOSACONAZOLEi3 Pharmaceuticals, LLCd5300d14-219d-4e1e-bfac-b413c40d6e3a2024-11-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216488
application number: ANDA216488
PosaconazolePOSACONAZOLEBryant Ranch Prepackd2daba09-f1c2-4764-a567-1291be4892b92024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216488
application number: ANDA216488

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POSACONAZOLE100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6TK1G07BHZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1482908Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4d14ceab-196e-4dc3-8b21-5c4629ada161Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc1eab98-5691-4d9a-82e4-7e2823a44fa6Product name920251124
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73141-023-02Posaconazole60 in 1 BOTTLETABLET, DELAYED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73141-023-02EA - Each73141-023423b4ab5-b591-4366-8ec2-91af27507f2512024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73141-023POSACONAZOLE TABLET, DELAYED RELEASE [A2A INTEGRATED PHARMACEUTICALS]2Current NDC, 1 package rows20250410_4d14ceab-196e-4dc3-8b21-5c4629ada161.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1482908posaconazole 100 MG Delayed Release Oral TabletPSN4d14ceab-196e-4dc3-8b21-5c4629ada1612
1482908posaconazole 100 MG Delayed Release Oral TabletSCD4d14ceab-196e-4dc3-8b21-5c4629ada1612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73141-023-027314100230260 TABLET, DELAYED RELEASE in 1 BOTTLE (73141-023-02) 2024-05-16NoNoCurrent