Cyproheptadine Hydrochloride Tablets, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-26
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 21:18:22

Label at a glance#

ProductCYPROHEPTADINE HYDROCHLORIDE

Active ingredientCYPROHEPTADINE HYDROCHLORIDE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1076-1

Cyproheptadine Hydrochloride Tablets USP, 4 mg

100 Tablets

R_xonly

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
866144	cyproheptadine HCl 4 MG Oral Tablet	PSN	5
866144	cyproheptadine hydrochloride 4 MG Oral Tablet	SCD	5

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
70771-1076-0	CYPROHEPTADINE HYDROCHLORIDE	1000 in 1 BOTTLE	TABLET	1000		5
70771-1076-1	CYPROHEPTADINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1076	CYPROHEPTADINE HYDROCHLORIDE TABLET [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 2 package rows	20241130_ccd7d3b2-b0c1-4f66-8d06-d21f5cfa8c1e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1076	70771-1076-1, 70771-1076-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CYPROHEPTADINE HYDROCHLORIDE	NJ82J0F8QC	ACTIB
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A208938-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208938-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	RS	2017-05-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208938-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2017-05-19	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A208938-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208938-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208938-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208938-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208938-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208938-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208938-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208938-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208938-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208938-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208938-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208938-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208938-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208938-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208938-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208938-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208938-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208938-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208938-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208938-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208938-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208938-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208938-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208938-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208938-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208938-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208938-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208938-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208938-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208938-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208938-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208938-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208938-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208938-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208938-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208938-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208938-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208938-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208938-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208938-001	AA	1	`3a93d1ddd44b…`

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 HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Zydus Lifesciences Limited	ccd7d3b2-b0c1-4f66-8d06-d21f5cfa8c1e	2024-11-26		Exact identifier ndc (package): 70771-1076-1 ndc (package): 70771-1076-0 ndc (product): 70771-1076 ndc11 (package): 70771107600 ndc11 (package): 70771107601 spl id: 465671c3-1e82-41d6-8ce4-b524d0032b15 spl set id: ccd7d3b2-b0c1-4f66-8d06-d21f5cfa8c1e

Reported adverse events (FAERS/openFDA)#

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