FDA.reportPublic FDA data

Fulvestrant

Product NDC
43598-262
11-digit product format
435980262
Labeler code
43598
Product ID
43598-262_67af235f-7f8b-da5b-5eb6-91d0b20b2a9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fulvestrant
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA209246
Marketing category
ANDA
Marketing start
2023-12-31
Substance
FULVESTRANT
Active strength
50 mg/mL
Pharmacologic classes
Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43598-26243598-262-02DDiscontinued by firm2026-08-11

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
A209246-001FULVESTRANTFULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209246-001AO

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
2026-02-19 14:30 UTC2026-02A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209246-001FULVESTRANT50MG/MLINJECTABLE / INTRAMUSCULARAO2020-08-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209246-001FULVESTRANT50MG/MLINJECTABLE / INTRAMUSCULARAO2020-08-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209246-001FULVESTRANT50MG/MLINJECTABLE / INTRAMUSCULARAO2020-08-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209246-001FULVESTRANT50MG/MLINJECTABLE / INTRAMUSCULARAO2020-08-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209246-001FULVESTRANT50MG/MLINJECTABLE / INTRAMUSCULARAO2020-08-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209246-001FULVESTRANT50MG/MLINJECTABLE / INTRAMUSCULARAO2020-08-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A209246-001FULVESTRANT50MG/MLINJECTABLE / INTRAMUSCULARAO2020-08-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209246-001FULVESTRANT50MG/MLINJECTABLE / INTRAMUSCULARAO2020-08-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209246-001FULVESTRANT50MG/MLINJECTABLE / INTRAMUSCULARAO2020-08-07c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209246-001FULVESTRANT50MG/MLINJECTABLE / INTRAMUSCULARAO2020-08-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209246-001FULVESTRANT50MG/MLINJECTABLE / INTRAMUSCULARAO2020-08-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209246-001FULVESTRANT50MG/MLINJECTABLE / INTRAMUSCULARAO2020-08-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209246-001AO1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209246-001AO131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209246-001AO16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209246-001AO1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209246-001AO1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209246-001AO103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209246-001AO12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209246-001AO15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209246-001AO1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209246-001AO1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209246-001AO179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209246-001AO1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209246-001AO11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209246-001AO18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209246-001AO15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209246-001AO15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209246-001AO14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A209246-001AO1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209246-001AO1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209246-001AO187673890dc5c…
2021-03-12 10:30 UTC2021-03A209246-001AO15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209246-001AO18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209246-001AO1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209246-001AO16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209246-001AO11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209246-001AO1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209246-001AO1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209246-001AO19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209246-001AO1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209246-001AO13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209246-001AO1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209246-001AO13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209246-001AO13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209246-001AO1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209246-001AO1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209246-001AO1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209246-001AO1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FULVESTRANT50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
22X328QOC4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
727762Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a809a83e-b49f-c569-2b4b-23ba590406b3Product name820240208
15aad051-0f67-42b5-934c-5fc8a73abadeProduct name120200213
3e4adb99-b829-4f50-ab9b-1e9b483563f6Product name120190821

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-262-02Fulvestrant2 in 1 CARTONINJECTION, SOLUTION219
43598-262-11Fulvestrant5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION519
43598-262-23Fulvestrant2 in 1 CARTONINJECTION, SOLUTION219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-262-02ML - Milliliter43598-262ffea5f6c-7731-4740-a3f9-edad8d056f4912020-09-14
43598-262-11ML - Milliliter43598-26203ff9a88-c9c3-4495-be64-9a6c0bc8384112020-09-14
43598-262-23ML - Milliliter43598-262a0670a5a-4694-44ec-9686-8ad95414921712024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-262FULVESTRANT INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC]19Current NDC, Legacy NDC, 3 package rows20240906_2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FulvestrantFULVESTRANTDr.Reddy's Laboratories Inc2fc17ba3-83c7-a2b4-8a75-6a0cb1e076822024-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209246
application number: ANDA209246
ndc (product): 43598-262

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSN2fc17ba3-83c7-a2b4-8a75-6a0cb1e0768219
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCD2fc17ba3-83c7-a2b4-8a75-6a0cb1e0768219
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSY2fc17ba3-83c7-a2b4-8a75-6a0cb1e0768219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-262-02435980262022 SYRINGE, GLASS in 1 CARTON (43598-262-02) / 5 mL in 1 SYRINGE, GLASS (43598-262-11) 2023-12-312026-05-31NoNoCurrent
43598-262-11435980262115 mL in 1 SYRINGE, GLASS5 mlHistorical
43598-262-23435980262232 SYRINGE, GLASS in 1 CARTON (43598-262-23) / 5 mL in 1 SYRINGE, GLASS (43598-262-11) 2024-09-05NoNoCurrent