CYPROHEPTADINE HYDROCHLORIDE

Product NDC: 70752-185
11-digit product format: 707520185
Labeler code: 70752
Product ID: 70752-185_4cf663f3-74cb-4b2c-b909-e6495d2ead78
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYPROHEPTADINE HYDROCHLORIDE
Dosage form: SOLUTION
Route: ORAL
Labeler: QUAGEN PHARMACEUTICALS LLC
Application: ANDA212423
Marketing category: ANDA
Marketing start: 2023-12-22
Substance: CYPROHEPTADINE HYDROCHLORIDE
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
A212423-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA		2019-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212423-001	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	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212423-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2019-05-22	`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	A212423-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212423-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212423-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212423-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212423-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212423-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212423-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212423-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212423-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212423-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212423-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212423-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212423-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212423-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212423-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212423-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212423-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212423-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212423-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212423-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212423-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212423-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212423-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212423-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212423-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A212423-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A212423-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212423-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212423-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212423-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212423-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212423-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212423-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212423-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212423-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212423-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212423-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212423-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212423-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212423-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: CYPROHEPTADINE HYDROCHLORIDE
Listing expiration: 2026-12-31

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
d3ce21de-849a-47ab-8405-968d8de6f1e9	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
70752-185-12	CYPROHEPTADINE HYDROCHLORIDE	473 mL in 1 BOTTLE, PLASTIC	SOLUTION	473		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70752-185-12	ML - Milliliter	70752-185	597b61e9-ef2b-4642-80a7-b290975f0ecc	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70752-185	CYPROHEPTADINE HYDROCHLORIDE SOLUTION [QUAGEN PHARMACEUTICALS LLC]	11	Current NDC, 1 package rows	20240616_d3ce21de-849a-47ab-8405-968d8de6f1e9.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	CYPROHEPTADINE HYDROCHLORIDE	Bryant Ranch Prepack	996dd4c6-ebcf-42e8-a950-9d34bb6f404f	2025-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212423 application number: ANDA212423
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	QUAGEN PHARMACEUTICALS LLC	d3ce21de-849a-47ab-8405-968d8de6f1e9	2024-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212423 application number: ANDA212423 ndc (product): 70752-185

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	d3ce21de-849a-47ab-8405-968d8de6f1e9	11
866021	cyproheptadine hydrochloride 0.4 MG/ML Oral Solution	SCD	d3ce21de-849a-47ab-8405-968d8de6f1e9	11
866021	cyproheptadine HCl 2 MG per 5 ML Oral Solution	SY	d3ce21de-849a-47ab-8405-968d8de6f1e9	11
866021	cyproheptadine HCl 4 MG per 10 ML Oral Syrup	SY	d3ce21de-849a-47ab-8405-968d8de6f1e9	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70752-185-12	70752018512	473 mL in 1 BOTTLE, PLASTIC (70752-185-12)	473 ml	2023-12-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyproheptadine Hydrochloride Oral Solution, USP, 2 mg/5 mL Rx only	QUAGEN PHARMACEUTICALS LLC	2024-06-15	HUMAN PRESCRIPTION DRUG LABEL	11