Cyproheptadine Hydrochloride

Product NDC: 10135-638
Requested package NDC: 10135-638-01
11-digit product format: 101350638
Labeler code: 10135
Product ID: 10135-638_ec99adbb-0476-1243-e053-2a95a90a568e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyproheptadine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA207555
Marketing category: ANDA
Marketing start: 2018-01-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	10135-638	10135-638-01	I	Inactivated by FDA		2026-08-11

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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 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
10135-638-01	2024-01-30	C162847	48780-1	1030e365-0355-111a-e063-dadaa90a10e2	Cyproheptadine Hydrochloride
10135-638-10	2024-01-30	C162847	48780-1	1030e365-0355-111a-e063-dadaa90a10e2	Cyproheptadine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-638-01	Cyproheptadine Hydrochloride	100 in 1 BOTTLE	TABLET	100		4
10135-638-10	Cyproheptadine Hydrochloride	1000 in 1 BOTTLE	TABLET	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-638-01	EA - Each	10135-638	b22e0324-9f63-4429-846f-e2269c1f8ab9	1	2018-02-20
10135-638-10	EA - Each	10135-638	c5feffbb-1da4-43e7-b822-7e97ea401f6e	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-638	CYPROHEPTADINE HYDROCHLORIDE TABLET [MARLEX PHARMACEUTICALS INC]	4	Legacy NDC, 2 package rows	20221104_c382a921-f801-4b63-885a-00e71d3c19c7.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
866144	cyproheptadine HCl 4 MG Oral Tablet	PSN	c382a921-f801-4b63-885a-00e71d3c19c7	4
866144	cyproheptadine hydrochloride 4 MG Oral Tablet	SCD	c382a921-f801-4b63-885a-00e71d3c19c7	4
866144	cyproheptadine HCl 4 MG Oral Tablet	PSN	42aa7300-0889-4f46-98fa-0f5d9546709b	1
866144	cyproheptadine hydrochloride 4 MG Oral Tablet	SCD	42aa7300-0889-4f46-98fa-0f5d9546709b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-638-01	10135063801	100 TABLET in 1 BOTTLE (10135-638-01)	100 tablet	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyproheptadine Hydrochloride	Marlex Pharmaceuticals Inc	2022-11-03	HUMAN PRESCRIPTION DRUG LABEL	4
Cyproheptadine Hydrochloride	A-S Medication Solutions	2019-12-03	HUMAN PRESCRIPTION DRUG LABEL	1