Cyproheptadine Hydrochloride

Product NDC: 50268-201
11-digit product format: 502680201
Labeler code: 50268
Product ID: 50268-201_426ac91c-cb7d-1fe3-e063-6394a90a1d4d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyproheptadine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA040537
Marketing category: ANDA
Marketing start: 2025-10-30
Substance: CYPROHEPTADINE HYDROCHLORIDE
Active strength: 4 mg/1
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 1.

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
A040537-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2003-09-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040537-001	AA

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 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040537-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2003-09-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040537-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040537-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040537-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040537-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040537-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040537-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040537-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040537-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040537-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040537-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040537-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040537-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040537-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040537-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040537-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040537-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040537-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040537-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040537-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040537-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040537-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040537-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040537-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040537-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040537-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040537-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040537-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040537-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040537-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040537-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040537-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040537-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040537-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040537-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040537-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040537-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040537-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040537-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040537-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040537-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Cyproheptadine Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYPROHEPTADINE HYDROCHLORIDE	4 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NJ82J0F8QC	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
866144	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
426acecc-aef4-099c-e063-6294a90a54eb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9917ef47-291c-0597-9549-0221b002efcd	Product name	7	20210804
67b21aa0-8a78-94d2-63ec-d7e6aa48ff6b	Product name	5	20190821

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-201-11	Cyproheptadine Hydrochloride	1 in 1 BLISTER PACK	TABLET	1		1
50268-201-15	Cyproheptadine Hydrochloride	50 in 1 BOX	TABLET	50		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-201-11	EA - Each	50268-201	f3f9e5db-6b96-4aba-bf52-8f2ef92fafe2	1	2025-12-16
50268-201-15	EA - Each	50268-201	82a2d7d1-4f63-4f74-b59b-6ffecf0257cc	1	2025-12-16

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	REMEDYREPACK INC.	80411af3-03ee-4330-830b-f69f2a373ef9	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040537 application number: ANDA040537
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Amneal Pharmaceuticals of New York LLC	80e13d3f-f4db-4bb4-95d5-5ac1afa70e7e	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040537 application number: ANDA040537
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	AvPAK	426acecc-aef4-099c-e063-6294a90a54eb	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040537 application number: ANDA040537 ndc (product): 50268-201
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	6a5b5a89-82c2-4991-b026-d160d8fa59a3	2024-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040537 application number: ANDA040537

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NJ82J0F8QC	CYPROHEPTADINE HYDROCHLORIDE	41354-29-4	CYPROHEPTADINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866144	cyproheptadine HCl 4 MG Oral Tablet	PSN	426acecc-aef4-099c-e063-6294a90a54eb	1
866144	cyproheptadine hydrochloride 4 MG Oral Tablet	SCD	426acecc-aef4-099c-e063-6294a90a54eb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50268-201-11	50268020111	1 in 1 BLISTER PACK					Historical
50268-201-15	50268020115	50 BLISTER PACK in 1 BOX (50268-201-15) / 1 TABLET in 1 BLISTER PACK (50268-201-11)	50 blister pack	2025-10-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyproheptadine Hydrochloride Tablets, USP (4 mg) Rx only	AvPAK	2025-10-30	HUMAN PRESCRIPTION DRUG LABEL	1