FDA.reportPublic FDA data

Fulvestrant

Product NDC
43598-262
11-digit product format
435980262
Labeler code
43598
Product ID
43598-262_711b8216-a850-2e78-bdb1-68c98787e8e5
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
2027-12-31
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 firm2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
2026-10-15 13:18:302026-09A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07c2088c7a36db…
2026-09-14 22:38:342026-08A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-0784e616aacf4f…
2026-08-18 06:07:402026-07A209246-001FULVESTRANT250MG/5ML (50MG/ML)SOLUTION / INTRAMUSCULARAO2020-08-07caaa826d4ba7…
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
2026-10-15 13:18:302026-09A209246-001AO1c2088c7a36db…
2026-09-14 22:38:342026-08A209246-001AO184e616aacf4f…
2026-08-18 06:07:402026-07A209246-001AO1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Fulvestrant
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FULVESTRANT50 mg/mL

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

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) 2020-08-170000-00-00NoNoCurrent
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