Cyproheptadine Hydrochloride

Product NDC
53808-1030
11-digit product format
538081030
Labeler code
53808
Product ID
53808-1030_432f511b-656e-4041-a595-c46a2e7a7b63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyproheptadine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA087056
Marketing category
ANDA
Marketing start
2014-11-01
Marketing end
0000-00-00
Substance
CYPROHEPTADINE HYDROCHLORIDE
Active strength
4 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53808-1030IInactivated by FDA2026-08-03
excluded packagepackage53808-103053808-1030-1IInactivated by FDA2026-08-03

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53808-1030-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53808-1030-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53808-1030-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53808-1030-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53808-1030-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53808-1030-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53808-1030-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53808-1030-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53808-1030-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53808-1030-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53808-1030-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53808-1030-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53808-1030-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53808-1030-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53808-1030-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53808-1030-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53808-1030-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53808-1030-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-1030-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-1030-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-1030-19bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A087056-001CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDE4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A087056-001CYPROHEPTADINE HYDROCHLORIDE4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALRLD, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087056-001CYPROHEPTADINE HYDROCHLORIDE4MGTABLET / ORALAARLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087056-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087056-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087056-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087056-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087056-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087056-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087056-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A087056-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087056-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087056-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087056-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A087056-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087056-001AA1ea99ee380514…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087056-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087056-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087056-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087056-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A087056-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A087056-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087056-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087056-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087056-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087056-001AA1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9917ef47-291c-0597-9549-0221b002efcdProduct name720210804
67b21aa0-8a78-94d2-63ec-d7e6aa48ff6bProduct name520190821

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-1030-12020-01-31C16284748780-19d75b9cf-d658-f424-e053-dadaa90a57ceCYPROHEPTADINE HYDROCHLORIDE TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-1030-1Cyproheptadine Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-1030CYPROHEPTADINE HYDROCHLORIDE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1Legacy NDC, 1 package rows20150107_9ffed85f-8c9f-49d3-8703-89ed9d2f1eec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866144cyproheptadine HCl 4 MG Oral TabletPSN9ffed85f-8c9f-49d3-8703-89ed9d2f1eec1
866144cyproheptadine hydrochloride 4 MG Oral TabletSCD9ffed85f-8c9f-49d3-8703-89ed9d2f1eec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-1030-15380810300130 in 1 BLISTER PACKHistorical