Home NDC 64980-690 Clomiphene Citrate
Product NDC 64980-690
11-digit product format 649800690
Labeler code 64980
Product ID 64980-690_621c3a1f-d194-4381-bde0-1574f108ac4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clomiphene Citrtae
Dosage form TABLET
Route ORAL
Labeler RISING PHARMA HOLDINGS, INC.
Application ANDA216739
Marketing category ANDA
Marketing start 2024-11-19
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 A216739-001 CLOMIPHENE CITRATE CLOMIPHENE CITRATE 50MG TABLET / ORAL AB 2024-11-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216739-001 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.
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 A216739-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB 2024-11-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216739-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB 2024-11-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216739-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB 2024-11-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216739-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB 2024-11-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216739-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB 2024-11-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216739-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB 2024-11-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216739-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB 2024-11-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216739-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB 2024-11-08 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216739-001 CLOMIPHENE CITRATE 50MG TABLET / ORAL AB 2024-11-08 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216739-001 CGT 2025-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216739-001 CGT 2025-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216739-001 CGT 2025-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216739-001 CGT 2025-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216739-001 CGT 2025-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216739-001 CGT 2025-05-18 2680178bc6a6…
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 64980-690-01 Clomiphene Citrate 10 in 1 BOTTLE TABLET 10 2 64980-690-03 Clomiphene Citrate 30 in 1 BOTTLE TABLET 30 2 64980-690-90 Clomiphene Citrate 1 in 1 CARTON TABLET 1 2 64980-690-90 Clomiphene Citrate 10 in 1 BLISTER PACK TABLET 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-690 CLOMIPHENE CITRATE (CLOMIPHENE CITRTAE) TABLET [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, 4 package rows 20241120_086eace1-51db-4d48-976c-9d39ef5be745.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 · 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 64980-690-01 64980069001 10 TABLET in 1 BOTTLE (64980-690-01) 10 tablet 2025-09-15 No No Current 64980-690-03 64980069003 30 TABLET in 1 BOTTLE (64980-690-03) 30 tablet 2024-11-19 No No Current 64980-690-90 64980069090 1 BLISTER PACK in 1 CARTON (64980-690-90) / 10 TABLET in 1 BLISTER PACK 1 blister pack 2025-09-15 No No Current