Cyproheptadine Hydrochloride

Product NDC: 52817-415
11-digit product format: 528170415
Labeler code: 52817
Product ID: 52817-415_1d668d93-8c9e-479e-ad8d-59656c8dec1b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyproheptadine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: TRUPHARMA, LLC
Application: ANDA206553
Marketing category: ANDA
Marketing start: 2026-06-01
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 43.

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
A206553-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2016-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206553-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206553-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2016-11-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A206553-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206553-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206553-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206553-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206553-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206553-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206553-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206553-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206553-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206553-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206553-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206553-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206553-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206553-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206553-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206553-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206553-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206553-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206553-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206553-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206553-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206553-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206553-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206553-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206553-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206553-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206553-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206553-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206553-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206553-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206553-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206553-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206553-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206553-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206553-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206553-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206553-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206553-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206553-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206553-001	AA	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
1d668d93-8c9e-479e-ad8d-59656c8dec1b	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	TRUPHARMA, LLC	9c0b47c0-ecd2-450f-9dcb-c262db92866e	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206553 application number: ANDA206553
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	dd2f3f0e-1bb8-432b-bcbb-01b4f550d022	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206553 application number: ANDA206553
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	TRUPHARMA, LLC	1d668d93-8c9e-479e-ad8d-59656c8dec1b	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206553 application number: ANDA206553 ndc (product): 52817-415
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	QPharma Inc	fc75bd79-63b7-6388-e053-6394a90ac377	2025-12-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206553 application number: ANDA206553
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	A-S Medication Solutions	7e156e5e-e4cc-420b-8f1a-af123eaa9156	2023-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206553 application number: ANDA206553

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	Sample	Exclude flag	Status
52817-415-10	52817041510	100 TABLET in 1 BOTTLE, PLASTIC (52817-415-10)	100 tablet	2026-06-01	No	No	Current
52817-415-50	52817041550	500 TABLET in 1 BOTTLE, PLASTIC (52817-415-50)	500 tablet	2026-06-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYPROHEPTADINE HYDROCHLORIDE TABLETS USP	TRUPHARMA, LLC \| Appco Pharma LLC	2026-07-14	Human Prescription Drug Label	1