DEFERIPRONE

Product NDC
75907-348
11-digit product format
759070348
Labeler code
75907
Product ID
75907-348_c3247274-c72a-4181-9638-58f7ff14729c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
deferiprone
Dosage form
TABLET, COATED
Route
ORAL
Labeler
DR. REDDY'S LABORATORIES, INC.
Application
ANDA220132
Marketing category
ANDA
Marketing start
2025-12-15
Substance
DEFERIPRONE
Active strength
1000 mg/1
Pharmacologic classes
Iron Chelating Activity [MoA], Iron Chelator [EPC]
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220132-001DEFERIPRONEDEFERIPRONE500MGTABLET / ORALAB2025-12-11
A220132-002DEFERIPRONEDEFERIPRONE1GMTABLET / ORALAB2025-12-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A220132-001AB
A220132-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A220132-001DEFERIPRONE500MGTABLET / ORALAB2025-12-11caaa826d4ba7…
2026-08-18 06:07:402026-07A220132-002DEFERIPRONE1GMTABLET / ORALAB2025-12-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220132-001DEFERIPRONE500MGTABLET / ORALAB2025-12-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A220132-002DEFERIPRONE1GMTABLET / ORALAB2025-12-11011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220132-001DEFERIPRONE500MGTABLET / ORALAB2025-12-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220132-002DEFERIPRONE1GMTABLET / ORALAB2025-12-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A220132-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A220132-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A220132-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A220132-002AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220132-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220132-002AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEFERIPRONE1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2BTY8KH53LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
389242Internal RxNorm lookup
2180997Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
67139215-1154-4e1a-ae15-0f3cd8af5177Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a80eb9dc-2190-fd13-788a-836e044e09a9Product name420210927
ee8776d9-85a0-4e53-8dc8-f4ae23ba4929Product name120201008
6708d2db-3abd-41fb-b674-120f69c5a63aProduct name120180621
222e639a-0425-48b8-8bdb-5ab1d9731285Product name120151028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-348-50DEFERIPRONE50 in 1 BOTTLETABLET, COATED501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-348-50EA - Each75907-34833f68899-7f67-4634-9675-192e4606b69712026-01-08

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
DEFERIPRONEDEFERIPRONEDR. REDDY'S LABORATORIES, INC.67139215-1154-4e1a-ae15-0f3cd8af51772025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220132
application number: ANDA220132
ndc (product): 75907-348

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2180997deferiprone 1000 MG Three-Times-A-Day Oral TabletPSN67139215-1154-4e1a-ae15-0f3cd8af51771
389242deferiprone 500 MG Three-Times-A-Day Oral TabletPSN67139215-1154-4e1a-ae15-0f3cd8af51771
2180997deferiprone 1000 MG Oral TabletSCD67139215-1154-4e1a-ae15-0f3cd8af51771
389242deferiprone 500 MG Oral TabletSCD67139215-1154-4e1a-ae15-0f3cd8af51771
2180997deferiprone 1000 MG Three-Times-A-Day Oral TabletSY67139215-1154-4e1a-ae15-0f3cd8af51771
389242deferiprone 500 MG Three-Times-A-Day Oral TabletSY67139215-1154-4e1a-ae15-0f3cd8af51771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
75907-348-507590703485050 TABLET, COATED in 1 BOTTLE (75907-348-50) 2025-12-15NoNoCurrent