CYPROHEPTADINE HYDROCHLORIDE

Product NDC: 70518-2414
Requested package NDC: 70518-2414-0
11-digit product format: 705182414
Labeler code: 70518
Product ID: 70518-2414_dbd4f07c-538f-2206-e053-2a95a90a5ef2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYPROHEPTADINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA209172
Marketing category: ANDA
Marketing start: 2019-11-11
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	70518-2414	70518-2414-0	D	Discontinued by firm		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 · 11 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…`

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
A209172-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2018-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209172-001	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	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209172-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2018-04-11	`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	A209172-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209172-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209172-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209172-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209172-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209172-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209172-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209172-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209172-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209172-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209172-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209172-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209172-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209172-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209172-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209172-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209172-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209172-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209172-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209172-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209172-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209172-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209172-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209172-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209172-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209172-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209172-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209172-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209172-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209172-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209172-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209172-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209172-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209172-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209172-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209172-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209172-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209172-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209172-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209172-001	AA	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Strides Pharma Science Limited	b28c2ca0-140d-44d8-a59e-75fbfe8eabdd	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209172 application number: ANDA209172
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	ab58d4df-69d4-43ac-ac6c-871fcc6c946d	2023-11-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209172 application number: ANDA209172

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
70518-2414-0	70518241400	30 TABLET in 1 BLISTER PACK (70518-2414-0)	30 tablet	2019-11-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYPROHEPTADINE HYDROCHLORIDE TABLETS USP Rx only	REMEDYREPACK INC.	2024-02-29	HUMAN PRESCRIPTION DRUG LABEL	6