Home NDC 83390-107 Clomiphene Citrate
Product NDC 83390-107
11-digit product format 833900107
Labeler code 83390
Product ID 83390-107_3ce28083-f9f3-c59f-e063-6394a90a92e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clomiphene Citrate
Dosage form TABLET
Route ORAL
Labeler Cosette Pharmaceuticals NC Laboratories, LLC
Application ANDA075528
Marketing category ANDA
Marketing start 2025-08-21
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 A075528-001 CLOMID CLOMIPHENE CITRATE 50MG TABLET / ORAL AB RS 1999-08-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075528-001 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 A075528-001 CLOMID 50MG TABLET / ORAL AB RS 1999-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB RS 1999-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB RS 1999-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB RS 1999-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB RS 1999-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB RS 1999-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB RS 1999-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB RS 1999-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075528-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL RS 1999-08-30 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Clomiphene Citrate
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1093060 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 83390-107-09 Clomiphene Citrate 10 in 1 BLISTER PACK TABLET 10 4 83390-107-09 Clomiphene Citrate 1 in 1 CARTON TABLET 1 4 83390-107-30 Clomiphene Citrate 10 in 1 BLISTER PACK TABLET 10 4 83390-107-30 Clomiphene Citrate 3 in 1 CARTON TABLET 3 4
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 · 3 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 83390-107-09 83390010709 1 BLISTER PACK in 1 CARTON (83390-107-09) / 10 TABLET in 1 BLISTER PACK 1 blister pack 2025-08-21 No No Current 83390-107-30 83390010730 3 BLISTER PACK in 1 CARTON (83390-107-30) / 10 TABLET in 1 BLISTER PACK 3 blister pack 2025-08-21 No No Current