CYPROHEPTADINE HYDROCHLORIDE

Product NDC: 53808-0950
11-digit product format: 538080950
Labeler code: 53808
Product ID: 53808-0950_087ab315-05c7-408a-85ab-e972c222bf89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYPROHEPTADINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA040537
Marketing category: ANDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: CYPROHEPTADINE HYDROCHLORIDE
Active strength: 4 mg/1
NDC exclude flag: E
Listing certified through: 2017-12-31
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	53808-0950		I	Inactivated by FDA		2026-08-03
excluded package	package	53808-0950	53808-0950-1	I	Inactivated by FDA		2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0950-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0950-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0950-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0950-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0950-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0950-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0950-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0950-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0950-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0950-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0950-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0950-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0950-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0950-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0950-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0950-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0950-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0950-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0950-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0950-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0950-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0950-1	`110d247fa046…`	`a55b01930146…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0950-1	2019-10-21	C162847	48780-1	956f9ecf-d113-621f-e053-dbdaa90a74ad	Cyproheptadine Hydrochloride Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0950-1	CYPROHEPTADINE HYDROCHLORIDE	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYPROHEPTADINE HYDROCHLORIDE	ACTIVE INGREDIENT	NJ82J0F8QC	CYPROHEPTADINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CYPROHEPTADINE	ACTIVE MOIETY	2YHB6175DO	CYPROHEPTADINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CYPROHEPTADINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	CYPROHEPTADINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CYPROHEPTADINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CYPROHEPTADINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0950	CYPROHEPTADINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100611_355d65a6-0681-475f-beb7-42980ec5ece5.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 · 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
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	355d65a6-0681-475f-beb7-42980ec5ece5	1
866144	cyproheptadine hydrochloride 4 MG Oral Tablet	SCD	355d65a6-0681-475f-beb7-42980ec5ece5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0950-1	53808095001	30 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyproheptadine Hydrochloride Tablets USP Rx only	State of Florida DOH Central Pharmacy	2010-05-21	HUMAN PRESCRIPTION DRUG LABEL	1