FDA.reportPublic FDA data

Amphotericin B liposome

Product NDC
67457-926
11-digit product format
674570926
Labeler code
67457
Product ID
67457-926_a96a734f-d1c4-4d42-93c2-7c336da7f7b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amphotericin B liposome
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Route
INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA212967
Marketing category
ANDA
Marketing start
2025-08-06
Substance
AMPHOTERICIN B
Active strength
50 mg/12.5mL
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212967-001AMPHOTERICIN BAMPHOTERICIN B50MG/VIALINJECTABLE, LIPOSOMAL / INJECTIONAB2025-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212967-001AB

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
2026-08-18 06:07:402026-07A212967-001AMPHOTERICIN B50MG/VIALINJECTABLE, LIPOSOMAL / INJECTIONAB2025-06-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212967-001AMPHOTERICIN B50MG/VIALINJECTABLE, LIPOSOMAL / INJECTIONAB2025-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212967-001AMPHOTERICIN B50MG/VIALINJECTABLE, LIPOSOMAL / INJECTIONAB2025-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A212967-001AMPHOTERICIN B50MG/VIALINJECTABLE, LIPOSOMAL / INJECTIONAB2025-06-306a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212967-001AMPHOTERICIN B50MG/VIALINJECTABLE, LIPOSOMAL / INJECTIONAB2025-06-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212967-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212967-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212967-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212967-001AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212967-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Amphotericin B liposome
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMPHOTERICIN B50 mg/12.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7XU7A7DROEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
967385Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a96a734f-d1c4-4d42-93c2-7c336da7f7b9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1a09ca27-c656-4f0b-83f8-43751bb90896Product name320260316
0021efff-57f3-bc98-886c-681a25ca5df1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-926-50Amphotericin B liposome12.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,12.51
67457-926-50Amphotericin B liposome1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11
67457-926-99Amphotericin B liposome10 in 1 BOXINJECTION, POWDER, LYOPHILIZED,101
67457-926-99Amphotericin B liposome1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-926-50EA - Each67457-92672740986-ecb1-4967-912b-6d1dc3331b1112025-09-12

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amphotericin B liposomeAMPHOTERICIN B LIPOSOMEMylan Institutional LLCa96a734f-d1c4-4d42-93c2-7c336da7f7b92025-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212967
application number: ANDA212967
ndc (product): 67457-926

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
967385amphotericin B liposomal 50 MG InjectionPSNa96a734f-d1c4-4d42-93c2-7c336da7f7b91
967385amphotericin B liposomal 50 MG InjectionSCDa96a734f-d1c4-4d42-93c2-7c336da7f7b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67457-926-50674570926501 VIAL, SINGLE-DOSE in 1 CARTON (67457-926-50) / 12.5 mL in 1 VIAL, SINGLE-DOSE2025-08-06NoNoCurrent
67457-926-996745709269910 in 1 BOXHistorical