Home NDC 35573-470 MiloPhene
Product NDC 35573-470
11-digit product format 355730470
Labeler code 35573
Product ID 35573-470_a7991ccf-26b1-4ab0-bf9e-175152dccfed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clomiphene Citrate
Dosage form TABLET
Route ORAL
Labeler Burel Pharmaceuticals, LLC
Application ANDA072196
Marketing category ANDA
Marketing start 2025-08-15
Substance CLOMIPHENE CITRATE
Active strength 50 mg/1
Pharmacologic classes Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
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 A072196-001 MILOPHENE CLOMIPHENE CITRATE 50MG TABLET / ORAL AB 1988-12-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072196-001 AB
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 A072196-001 MILOPHENE 50MG TABLET / ORAL AB 1988-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072196-001 MILOPHENE 50MG TABLET / ORAL AB 1988-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072196-001 MILOPHENE 50MG TABLET / ORAL AB 1988-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072196-001 MILOPHENE 50MG TABLET / ORAL 1988-12-20 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A072196-001 AB 1 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A072196-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072196-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A072196-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base MiloPhene
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLOMIPHENE CITRATE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1B8447E7YI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1093060 Internal RxNorm lookup 2723329 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 35573-470-30 MiloPhene 30 in 1 BOTTLE TABLET 30 2 35573-470-75 MiloPhene 10 in 1 BOTTLE TABLET 10 2
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 Sample Exclude flag Status 35573-470-30 35573047030 30 TABLET in 1 BOTTLE (35573-470-30) 30 tablet 2025-08-15 No No Current 35573-470-75 35573047075 10 TABLET in 1 BOTTLE (35573-470-75) 10 tablet 2025-12-01 No No Current