CYPROHEPTADINE

Product NDC: 62135-949
11-digit product format: 621350949
Labeler code: 62135
Product ID: 62135-949_06fd9a7b-3b04-6e0c-e063-6394a90aba46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYPROHEPTADINE HYDROCHLORIDE
Dosage form: SYRUP
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA203191
Marketing category: ANDA
Marketing start: 2017-07-13
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
A203191-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA		2017-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203191-001	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	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203191-001	CYPROHEPTADINE HYDROCHLORIDE	2MG/5ML	SYRUP / ORAL	AA	2017-07-13	`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	A203191-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203191-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203191-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203191-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203191-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203191-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203191-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203191-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203191-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203191-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203191-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203191-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203191-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203191-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203191-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203191-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203191-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203191-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203191-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203191-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203191-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203191-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203191-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203191-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203191-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203191-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203191-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203191-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203191-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203191-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203191-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203191-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203191-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203191-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203191-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203191-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203191-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203191-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203191-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203191-001	AA	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: CYPROHEPTADINE
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
37fe7264-4d45-4d6c-ac13-40fcd1d82351	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
62135-949-47	CYPROHEPTADINE	473 mL in 1 BOTTLE	SYRUP	473		3
62135-949-94	CYPROHEPTADINE	946 mL in 1 BOTTLE	SYRUP	946		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-949-47	ML - Milliliter	62135-949	3dccc7af-3e57-4fc5-84c6-ff0af8f3dc8c	1	2022-09-12
62135-949-94	ML - Milliliter	62135-949	6baa70d2-8fcc-4d8c-946e-3f9de7c3b264	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-949	CYPROHEPTADINE (CYPROHEPTADINE HYDROCHLORIDE) SYRUP [CHARTWELL RX, LLC]	3	Current NDC, Legacy NDC, 2 package rows	20231006_37fe7264-4d45-4d6c-ac13-40fcd1d82351.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CYPROHEPTADINE	CYPROHEPTADINE HYDROCHLORIDE	Chartwell RX, LLC	37fe7264-4d45-4d6c-ac13-40fcd1d82351	2023-10-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203191 application number: ANDA203191 ndc (product): 62135-949

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	37fe7264-4d45-4d6c-ac13-40fcd1d82351	3
866021	cyproheptadine hydrochloride 0.4 MG/ML Oral Solution	SCD	37fe7264-4d45-4d6c-ac13-40fcd1d82351	3
866021	cyproheptadine HCl 2 MG per 5 ML Oral Solution	SY	37fe7264-4d45-4d6c-ac13-40fcd1d82351	3
866021	cyproheptadine HCl 4 MG per 10 ML Oral Syrup	SY	37fe7264-4d45-4d6c-ac13-40fcd1d82351	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
62135-949-47	62135094947	473 mL in 1 BOTTLE (62135-949-47)	473 ml	2022-07-13	0000-00-00	No	No	Current
62135-949-94	62135094994	946 mL in 1 BOTTLE (62135-949-94)	946 ml	2022-07-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution, USP) 2 mg/5 mL Rx Only	Chartwell RX, LLC	2023-10-05	HUMAN PRESCRIPTION DRUG LABEL	3