cyproheptadine hydrochloride solution

Product NDC: 58657-697
11-digit product format: 586570697
Labeler code: 58657
Product ID: 58657-697_41b48ab2-962e-790a-e063-6394a90a6106
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYPROHEPTADINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: ORAL
Labeler: Method Pharmaceuticals, LLC
Application: ANDA209108
Marketing category: ANDA
Marketing start: 2024-06-15
Substance: CYPROHEPTADINE
Active strength: 2 mg/5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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
A209108-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA		2018-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209108-001	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	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209108-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2018-10-16	`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	A209108-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209108-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209108-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209108-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209108-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209108-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209108-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209108-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209108-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209108-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209108-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209108-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209108-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209108-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209108-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209108-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209108-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209108-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209108-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209108-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209108-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209108-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209108-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209108-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209108-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209108-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209108-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209108-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209108-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209108-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209108-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209108-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209108-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209108-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209108-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209108-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209108-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209108-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209108-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209108-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: cyproheptadine hydrochloride solution
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CYPROHEPTADINE	2 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2YHB6175DO	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
1acfd050-6c07-a269-e063-6394a90a77e8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
9917ef47-291c-0597-9549-0221b002efcd	Product name	7	20210804
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
67b21aa0-8a78-94d2-63ec-d7e6aa48ff6b	Product name	5	20190821
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
58657-697-16	cyproheptadine hydrochloride solution	473 mL in 1 BOTTLE, GLASS	SOLUTION	473		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58657-697-16	ML - Milliliter	58657-697	ebafd83f-b940-422b-b58b-e4011ab3e5a5	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58657-697	CYPROHEPTADINE HYDROCHLORIDE SOLUTION (CYPROHEPTADINE HYDROCHLORIDE) SOLUTION [METHOD PHARMACEUTICALS, LLC]	1	Current NDC, 1 package rows	20240817_1acfd050-6c07-a269-e063-6394a90a77e8.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cyproheptadine hydrochloride solution	CYPROHEPTADINE HYDROCHLORIDE	Method Pharmaceuticals, LLC	1acfd050-6c07-a269-e063-6394a90a77e8	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209108 application number: ANDA209108 ndc (product): 58657-697
Cyproheptadine Hydrochloride	CYPROHEPTADINE HYDROCHLORIDE	Patrin Pharma, Inc.	81d9523f-f945-4410-8b71-8b5fea48a3da	2022-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209108 application number: ANDA209108

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2YHB6175DO	CYPROHEPTADINE	129-03-3	CYPROHEPTADINE
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	1acfd050-6c07-a269-e063-6394a90a77e8	2
866021	cyproheptadine hydrochloride 0.4 MG/ML Oral Solution	SCD	1acfd050-6c07-a269-e063-6394a90a77e8	2
866021	cyproheptadine HCl 2 MG per 5 ML Oral Solution	SY	1acfd050-6c07-a269-e063-6394a90a77e8	2
866021	cyproheptadine HCl 4 MG per 10 ML Oral Syrup	SY	1acfd050-6c07-a269-e063-6394a90a77e8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
58657-697-16	58657069716	473 mL in 1 BOTTLE, GLASS (58657-697-16)	473 ml	2024-06-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
cyproheptadine hydrochloride solution - Method Pharmaceuticals, LLC	Method Pharmaceuticals, LLC	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	2