Cyproheptadine Hydrochloride

Product NDC: 17856-0504
11-digit product format: 178560504
Labeler code: 17856
Product ID: 17856-0504_50b39d04-bda7-78bd-e063-6294a90a490d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyproheptadine Hydrochloride
Dosage form: SYRUP
Route: ORAL
Labeler: Atlantic Biological Corp.
Application: ANDA040668
Marketing category: ANDA
Marketing start: 2006-07-10
Substance: CYPROHEPTADINE HYDROCHLORIDE
Active strength: 2 mg/5mL
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 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
A040668-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040668-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040668-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	RS	2006-06-28	`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	A040668-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040668-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040668-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040668-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040668-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040668-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040668-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040668-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040668-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040668-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040668-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040668-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040668-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040668-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040668-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040668-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040668-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040668-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040668-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040668-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040668-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040668-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040668-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040668-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040668-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040668-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040668-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040668-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040668-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040668-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040668-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040668-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040668-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040668-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040668-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040668-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040668-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040668-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040668-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040668-001	AA	1	`cb3db0bc1861…`

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	2 mg/5mL

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
866021	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
50b3abc0-d86a-e8f5-e063-6394a90ad25e	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17856-0504-1	Cyproheptadine Hydrochloride	120 in 1 CASE	SYRUP	120		1
17856-0504-1	Cyproheptadine Hydrochloride	2.5 mL in 1 SYRINGE	SYRUP	2.5		1

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	Atlantic Biological Corp.	50b3abc0-d86a-e8f5-e063-6394a90ad25e	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040668 application number: ANDA040668 ndc (product): 17856-0504
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	e2bf4d46-6585-41d9-868c-98603b165d5b	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040668 application number: ANDA040668

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
866021	cyproheptadine HCl 2 MG in 5 mL Oral Solution	PSN	50b3abc0-d86a-e8f5-e063-6394a90ad25e	1
866021	cyproheptadine hydrochloride 0.4 MG/ML Oral Solution	SCD	50b3abc0-d86a-e8f5-e063-6394a90ad25e	1
866021	cyproheptadine HCl 2 MG per 5 ML Oral Solution	SY	50b3abc0-d86a-e8f5-e063-6394a90ad25e	1
866021	cyproheptadine HCl 4 MG per 10 ML Oral Syrup	SY	50b3abc0-d86a-e8f5-e063-6394a90ad25e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
17856-0504-1	17856050401	120 SYRINGE in 1 CASE (17856-0504-1) / 2.5 mL in 1 SYRINGE	120 syringe	2026-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution, USP)	Atlantic Biological Corp.	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	1