Clomiphene Citrate

Product NDC: 68071-2638
11-digit product format: 680712638
Labeler code: 68071
Product ID: 68071-2638_d7392d9a-6377-2db2-e053-2995a90a53cd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clomiphene Citrate
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA075528
Marketing category: ANDA
Marketing start: 1999-08-30
Marketing end: 0000-00-00
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: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-2638		I	Inactivated by FDA		2026-08-17
excluded package	package	68071-2638	68071-2638-3	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2638-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2638-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2638-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2638-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2638-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2638-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2638-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2638-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2638-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075528-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075528-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075528-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075528-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075528-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075528-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075528-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075528-001	AB	1	`2680178bc6a6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075528-001	AB	1	`a50c72e98297…`

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2638-3	2025-01-30	C162847	48780-1	2cef2736-aa3d-d83d-e063-dadaa90ab31f	Clomiphene Citrate Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2638-3	Clomiphene Citrate	30 in 1 CARTON	TABLET	30		1
68071-2638-3	Clomiphene Citrate	10 in 1 BLISTER PACK	TABLET	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2638	CLOMIPHENE CITRATE TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 2 package rows	20220205_d7392d9a-6378-2db2-e053-2995a90a53cd.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 CITRATE	Cosette Pharmaceuticals NC Laboratories, LLC	72719958-7454-4c54-9bb4-f3054d0c5d82	2025-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075528 application number: ANDA075528
Clomid	CLOMIPHENE CITRATE	Cosette Pharmaceuticals, Inc.	2ca373c1-4dba-4126-8616-5c533d606fe5	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075528 application number: ANDA075528
CLOMID	CLOMIPHENE CITRATE	A-S Medication Solutions	f15e9918-6001-4150-bd54-1364a6febcb8	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075528 application number: ANDA075528

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	d7392d9a-6378-2db2-e053-2995a90a53cd	1
1093060	clomiphene citrate 50 MG Oral Tablet	SCD	d7392d9a-6378-2db2-e053-2995a90a53cd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2638-3	68071263803	30 BLISTER PACK in 1 CARTON (68071-2638-3) > 10 TABLET in 1 BLISTER PACK	30 blister pack	1999-09-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clomiphene Citrate Tablets	NuCare Pharmaceuticals,Inc.	2022-02-04	HUMAN PRESCRIPTION DRUG LABEL	1