CYPROHEPTADINE HYDROCHLORIDE

Product NDC: 51407-272
11-digit product format: 514070272
Labeler code: 51407
Product ID: 51407-272_3bb806b9-3446-4211-e063-6394a90aff66
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CYPROHEPTADINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Golden State Medical Supply, Inc.
Application: ANDA205087
Marketing category: ANDA
Marketing start: 2015-09-23
Substance: CYPROHEPTADINE HYDROCHLORIDE
Active strength: 4 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51407-272	51407-272-01	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A205087-001	CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA		2015-09-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205087-001	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	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205087-001	CYPROHEPTADINE HYDROCHLORIDE	4MG	TABLET / ORAL	AA	2015-09-23	`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	A205087-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205087-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205087-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205087-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205087-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205087-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205087-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205087-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205087-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205087-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205087-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205087-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205087-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205087-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205087-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205087-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205087-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205087-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205087-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205087-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205087-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205087-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205087-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205087-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205087-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205087-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205087-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205087-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205087-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205087-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205087-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205087-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205087-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205087-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205087-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205087-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205087-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205087-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205087-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205087-001	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	4 mg/1

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
866144	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
95c03949-0e9a-e3b5-e053-2995a90a56b6	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
51407-272-01	CYPROHEPTADINE HYDROCHLORIDE	100 in 1 BOTTLE, PLASTIC	TABLET	100		4
51407-272-10	CYPROHEPTADINE HYDROCHLORIDE	1000 in 1 BOTTLE, PLASTIC	TABLET	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51407-272-01	EA - Each	51407-272	3f1e4580-4ccc-4e21-a142-a5b804d3147d	1	2019-12-10
51407-272-10	EA - Each	51407-272	9b30df45-899d-4a2d-8527-72047bf74e4a	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51407-272	CYPROHEPTADINE HYDROCHLORIDE TABLET [GOLDEN STATE MEDICAL SUPPLY]	3	Current NDC, Legacy NDC, 2 package rows	20221206_95c03949-0e9a-e3b5-e053-2995a90a56b6.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	Golden State Medical Supply, Inc.	95c03949-0e9a-e3b5-e053-2995a90a56b6	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205087 application number: ANDA205087 ndc (product): 51407-272
CYPROHEPTADINE HYDROCHLORIDE	CYPROHEPTADINE HYDROCHLORIDE	Ingenus Pharmaceuticals LLC	56f428c9-8d33-4c91-91d8-1fe194335066	2025-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205087 application number: ANDA205087

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
866144	cyproheptadine HCl 4 MG Oral Tablet	PSN	95c03949-0e9a-e3b5-e053-2995a90a56b6	4
866144	cyproheptadine hydrochloride 4 MG Oral Tablet	SCD	95c03949-0e9a-e3b5-e053-2995a90a56b6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51407-272-01	51407027201	100 TABLET in 1 BOTTLE, PLASTIC (51407-272-01)	100 tablet	2019-08-22	0000-00-00	No	No	Current
51407-272-10	51407027210	1000 TABLET in 1 BOTTLE, PLASTIC (51407-272-10)	1000 tablet	2019-08-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CYPROHEPTADINE HYDROCHLORIDE TABLETS, USP Rx only	Golden State Medical Supply, Inc.	2025-08-06	HUMAN PRESCRIPTION DRUG LABEL	4