CYPROHEPTADINE HYDROCHLORIDE

Product NDC: 70518-3517
11-digit product format: 705183517
Labeler code: 70518
Product ID: 70518-3517_4f1ffe50-29f4-fe99-e063-6294a90a2ceb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYPROHEPTADINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA212491
Marketing category: ANDA
Marketing start: 2022-09-13
Substance: CYPROHEPTADINE HYDROCHLORIDE
Active strength: 4 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A212491-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2021-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212491-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212491-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2021-02-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212491-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212491-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212491-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212491-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212491-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212491-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212491-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212491-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212491-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212491-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212491-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212491-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212491-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212491-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212491-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212491-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212491-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212491-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212491-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212491-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212491-001	AA	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212491-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212491-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212491-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212491-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212491-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212491-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212491-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212491-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212491-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212491-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212491-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212491-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212491-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212491-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: CYPROHEPTADINE HYDROCHLORIDE
Listing expiration: 2027-12-31

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
7b3aed50-cc9e-4897-9735-361225e9e5f2	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
70518-3517-0	CYPROHEPTADINE HYDROCHLORIDE	30 in 1 BLISTER PACK	TABLET	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3517	CYPROHEPTADINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240322_7b3aed50-cc9e-4897-9735-361225e9e5f2.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	REMEDYREPACK INC.	7b3aed50-cc9e-4897-9735-361225e9e5f2	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212491 application number: ANDA212491 ndc (product): 70518-3517
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	QPharma Inc	1dfe4478-76d9-9b8f-e063-6394a90aefe8	2025-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212491 application number: ANDA212491
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	22eaef18-b5cc-421a-910e-d569f00b4599	2025-11-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212491 application number: ANDA212491
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	5d0db096-f35d-4065-bff1-2fd7ef5a1a6f	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212491 application number: ANDA212491
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	1bfb14ad-b522-4ad6-8c9f-2d99dd0dce64	2023-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212491 application number: ANDA212491
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	QUAGEN PHARMACEUTICALS LLC	98e71865-83dd-4e29-8308-c56e36731d96	2022-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212491 application number: ANDA212491

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	7b3aed50-cc9e-4897-9735-361225e9e5f2	5
866144	cyproheptadine hydrochloride 4 MG Oral Tablet	SCD	7b3aed50-cc9e-4897-9735-361225e9e5f2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3517-0	70518351700	30 TABLET in 1 BLISTER PACK (70518-3517-0)	30 tablet	2022-09-13	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.	2026-04-10	HUMAN PRESCRIPTION DRUG LABEL	5