Home NDC 0049-0116 ERAXIS
Product NDC 0049-0116
11-digit product format 000490116
Labeler code 0049
Product ID 0049-0116_f59883f3-edec-4246-a236-790cc492fdb9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name anidulafungin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Roerig
Application NDA021632
Marketing category NDA
Marketing start 2006-02-17
Substance ANIDULAFUNGIN
Active strength 100 mg/30mL
Pharmacologic classes Echinocandin Antifungal [EPC], Lipopeptides [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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021632-001 ERAXIS ANIDULAFUNGIN 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 N021632-002 ERAXIS ANIDULAFUNGIN 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14
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 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021632-001 ERAXIS 50MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-02-17 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021632-002 ERAXIS 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2006-11-14 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 2 · 48 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021632-001 5965525 2020-02-17 U-540 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021632-001 6960564 2021-04-12 U-540 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021632-001 7709444 2021-04-12 U-540 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021632-002 5965525 2020-02-17 U-540 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021632-002 6960564 2021-04-12 U-540 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021632-002 7709444 2021-04-12 U-540 Drug product 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021632-001 6960564 2021-04-12 U-540 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021632-001 7709444 2021-04-12 U-540 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021632-002 6960564 2021-04-12 U-540 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021632-002 7709444 2021-04-12 U-540 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021632-001 6960564 2021-04-12 U-540 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021632-001 7709444 2021-04-12 U-540 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021632-002 6960564 2021-04-12 U-540 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021632-002 7709444 2021-04-12 U-540 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021632-001 6960564 2021-04-12 U-540 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021632-001 7709444 2021-04-12 U-540 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021632-002 6960564 2021-04-12 U-540 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021632-002 7709444 2021-04-12 U-540 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021632-001 5965525 2020-02-17 U-540 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021632-001 6960564 2021-04-12 U-540 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021632-001 7709444 2021-04-12 U-540 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021632-002 5965525 2020-02-17 U-540 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021632-002 6960564 2021-04-12 U-540 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021632-002 7709444 2021-04-12 U-540 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021632-001 5965525 2020-02-17 U-540 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021632-001 6960564 2021-04-12 U-540 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021632-001 7709444 2021-04-12 U-540 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021632-002 5965525 2020-02-17 U-540 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021632-002 6960564 2021-04-12 U-540 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021632-002 7709444 2021-04-12 U-540 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021632-001 5965525 2020-02-17 U-540 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021632-001 6960564 2021-04-12 U-540 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021632-001 7709444 2021-04-12 U-540 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021632-002 5965525 2020-02-17 U-540 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021632-002 6960564 2021-04-12 U-540 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021632-002 7709444 2021-04-12 U-540 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021632-001 5965525 2020-02-17 U-540 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021632-001 6960564 2021-04-12 U-540 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021632-001 7709444 2021-04-12 U-540 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021632-002 5965525 2020-02-17 U-540 Drug substance, Drug product b00525d2431f…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base ERAXIS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANIDULAFUNGIN 100 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9HLM53094I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1804743 Internal RxNorm lookup 1804746 Internal RxNorm lookup 1804748 Internal RxNorm lookup 1804750 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0049-0116-28 ERAXIS 30 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 30 24
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ANIDULAFUNGIN ACTIVE INGREDIENT 9HLM53094I ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 11 ANIDULAFUNGIN ACTIVE MOIETY 9HLM53094I ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 11 FRUCTOSE INACTIVE INGREDIENT 6YSS42VSEV ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 11 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 11 MANNITOL INACTIVE INGREDIENT 3OWL53L36A ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 11 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 11 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 11 TARTARIC ACID INACTIVE INGREDIENT W4888I119H ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0049-0116 ERAXIS (ANIDULAFUNGIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ROERIG] 23 Current NDC, Legacy NDC, 1 package rows 20240302_a88d9010-55fb-4a02-baff-042cd27688ea.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0049-0116-28 00049011628 30 mL in 1 VIAL, SINGLE-USE (0049-0116-28) 30 ml 2006-02-17 0000-00-00 No No Current