Cyproheptadine Hydrochloride

Product NDC: 50268-189
11-digit product format: 502680189
Labeler code: 50268
Product ID: 50268-189_ed851b79-b74a-4e6e-e053-2a95a90ae7ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyproheptadine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA207555
Marketing category: ANDA
Marketing start: 2021-03-22
Marketing end: 0000-00-00
Substance: CYPROHEPTADINE HYDROCHLORIDE
Active strength: 4 mg/1
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	50268-189		D	Discontinued by firm		2026-08-11
excluded package	package	50268-189	50268-189-15	D	Discontinued by firm		2026-08-11

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
A207555-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207555-001	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	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207555-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2017-01-31	`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	A207555-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207555-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207555-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207555-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207555-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207555-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207555-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207555-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207555-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207555-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207555-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207555-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207555-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207555-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207555-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207555-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207555-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207555-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207555-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207555-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207555-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207555-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207555-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207555-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207555-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207555-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207555-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207555-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207555-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207555-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207555-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207555-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207555-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207555-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207555-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207555-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207555-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207555-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207555-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207555-001	AA	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-189-11	EA - Each	50268-189	4f5ab03d-f4ad-4a5a-9f5a-eef95da950ee	1	2021-04-08
50268-189-15	EA - Each	50268-189	d69541d2-fa50-46a6-90f8-eaf65a208267	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-189	CYPROHEPTADINE HYDROCHLORIDE TABLET [AVPAK]	3	Legacy NDC	20240110_be26ceb6-7655-9cef-e053-2a95a90af6d9.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	c5e9e983-d0d2-4f87-beae-0d853ca43983	2022-02-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207555 application number: ANDA207555

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-189-15	50268018915	50 BLISTER PACK in 1 BOX (50268-189-15) > 1 TABLET in 1 BLISTER PACK (50268-189-11)	50 blister pack	2021-03-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyproheptadine Hydrochloride Tablets, USP Rx Only	AvPAK	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	3