Home NDC 39822-1055 Amphotericin B
Product NDC 39822-1055
11-digit product format 398221055
Labeler code 39822
Product ID 39822-1055_ff6c6de5-ba12-4176-817f-359761f6e4bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Amphotericin B
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler XGen Pharmaceuticals DJB, Inc.
Application ANDA063206
Marketing category ANDA
Marketing start 1992-04-29
Substance AMPHOTERICIN B
Active strength 50 mg/10mL
Pharmacologic classes Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A063206-001 AMPHOTERICIN B AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A063206-001 AMPHOTERICIN B 50MG/VIAL INJECTABLE / INJECTION RS 1992-04-29 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base Amphotericin B
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPHOTERICIN B 50 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7XU7A7DROE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 239240 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 39822-1055-5 Amphotericin B 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMPHOTERICIN B ACTIVE INGREDIENT 7XU7A7DROE AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 10 AMPHOTERICIN B ACTIVE MOIETY 7XU7A7DROE AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 10 DEOXYCHOLIC ACID INACTIVE INGREDIENT 005990WHZZ AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 10 NITROGEN INACTIVE INGREDIENT N762921K75 AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 10 PHOSPHORIC ACID INACTIVE INGREDIENT E4GA8884NN AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 10 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 10 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 10 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39822-1055 AMPHOTERICIN B INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] 13 Current NDC, Legacy NDC, 1 package rows 20220121_a0a54943-9ce4-4f3e-b681-a1a9144c16ce.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.
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 39822-1055-5 39822105505 10 mL in 1 VIAL (39822-1055-5) 10 ml 1992-04-29 0000-00-00 No No Current