Clomiphene Citrate

Product NDC: 55801-187
11-digit product format: 558010187
Labeler code: 55801
Product ID: 55801-187_b22cc371-c969-4446-8cba-32a7e469ae80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clomiphene Citrtae
Dosage form: TABLET
Route: ORAL
Labeler: Appco Pharma LLC
Application: ANDA216739
Marketing category: ANDA
Marketing start: 2024-11-18
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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A216739-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216739-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216739-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216739-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216739-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216739-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216739-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216739-001	AB	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216739-001	AB	1	`a50c72e98297…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2d257ec2-827c-4bc2-8f17-cf24520c3cad	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c924cb97-cd84-d0fe-8911-51a8a0fb2420	Product name	2	20250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55801-187-01	Clomiphene Citrate	30 in 1 BOTTLE	TABLET	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55801-187	CLOMIPHENE CITRATE (CLOMIPHENE CITRTAE) TABLET [APPCO PHARMA LLC]	4	Current NDC, 1 package rows	20241201_2d257ec2-827c-4bc2-8f17-cf24520c3cad.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clomiphene Citrate	CLOMIPHENE CITRTAE	Acetris Pharma Holdings, LLC	76c7550a-d527-4925-b19f-d8b52d567474	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216739 application number: ANDA216739
Clomiphene Citrate	CLOMIPHENE CITRTAE	RISING PHARMA HOLDINGS, INC.	086eace1-51db-4d48-976c-9d39ef5be745	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216739 application number: ANDA216739
Clomiphene Citrate	CLOMIPHENE CITRTAE	Appco Pharma LLC	2d257ec2-827c-4bc2-8f17-cf24520c3cad	2024-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216739 application number: ANDA216739 ndc (product): 55801-187

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1B8447E7YI	CLOMIPHENE CITRATE	50-41-9	CLOMIPHENE CITRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1093060	clomiPHENE citrate 50 MG Oral Tablet	PSN	2d257ec2-827c-4bc2-8f17-cf24520c3cad	4
1093060	clomiphene citrate 50 MG Oral Tablet	SCD	2d257ec2-827c-4bc2-8f17-cf24520c3cad	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55801-187-01	55801018701	30 TABLET in 1 BOTTLE (55801-187-01)	30 tablet	2024-11-18	No	No	Current