Cyproheptadine Hydrochloride

Product NDC
64980-504
11-digit product format
649800504
Labeler code
64980
Product ID
64980-504_9b4845c1-9b59-4809-9247-50565fc4b6fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyproheptadine Hydrochloride
Dosage form
SYRUP
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA040668
Marketing category
ANDA
Marketing start
2006-07-10
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040668-001CYPROHEPTADINE HYDROCHLORIDECYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040668-001AA

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 UTC2026-02A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-283f01610625f2…
2019-09-15 20:21 UTC2019-09A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040668-001CYPROHEPTADINE HYDROCHLORIDE2MG/5MLSYRUP / ORALAARS2006-06-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040668-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040668-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040668-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040668-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040668-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040668-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040668-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040668-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040668-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040668-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040668-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040668-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040668-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040668-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040668-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040668-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040668-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040668-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040668-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040668-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040668-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040668-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040668-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040668-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040668-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040668-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040668-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040668-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040668-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040668-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040668-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040668-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040668-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040668-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040668-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040668-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040668-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040668-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040668-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040668-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Cyproheptadine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYPROHEPTADINE HYDROCHLORIDE2 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NJ82J0F8QCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
866021Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e2bf4d46-6585-41d9-868c-98603b165d5bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9917ef47-291c-0597-9549-0221b002efcdProduct name720210804
67b21aa0-8a78-94d2-63ec-d7e6aa48ff6bProduct name520190821
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-504-48Cyproheptadine Hydrochloride473 mL in 1 BOTTLESYRUP4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-504-48ML - Milliliter64980-50412035111-1990-4687-b8be-42eff4f6f72512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-504CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMA HOLDINGS, INC.]9Current NDC, Legacy NDC, 1 package rows20250402_e2bf4d46-6585-41d9-868c-98603b165d5b.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDEAtlantic Biological Corp.50b3abc0-d86a-e8f5-e063-6394a90ad25e2026-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040668
application number: ANDA040668
Cyproheptadine HydrochlorideCYPROHEPTADINE HYDROCHLORIDERising Pharma Holdings, Inc.e2bf4d46-6585-41d9-868c-98603b165d5b2025-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040668
application number: ANDA040668
ndc (product): 64980-504

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866021cyproheptadine HCl 2 MG in 5 mL Oral SolutionPSNe2bf4d46-6585-41d9-868c-98603b165d5b9
866021cyproheptadine hydrochloride 0.4 MG/ML Oral SolutionSCDe2bf4d46-6585-41d9-868c-98603b165d5b9
866021cyproheptadine HCl 2 MG per 5 ML Oral SolutionSYe2bf4d46-6585-41d9-868c-98603b165d5b9
866021cyproheptadine HCl 4 MG per 10 ML Oral SyrupSYe2bf4d46-6585-41d9-868c-98603b165d5b9
866021cyproheptadine HCl 2 MG in 5 mL Oral SolutionPSN949743a7-f922-4248-aa28-818236c80a672
866021cyproheptadine hydrochloride 0.4 MG/ML Oral SolutionSCD949743a7-f922-4248-aa28-818236c80a672
866021cyproheptadine HCl 2 MG per 5 ML Oral SolutionSY949743a7-f922-4248-aa28-818236c80a672
866021cyproheptadine HCl 4 MG per 10 ML Oral SyrupSY949743a7-f922-4248-aa28-818236c80a672
866021cyproheptadine HCl 2 MG in 5 mL Oral SolutionPSN50b3abc0-d86a-e8f5-e063-6394a90ad25e1
866021cyproheptadine hydrochloride 0.4 MG/ML Oral SolutionSCD50b3abc0-d86a-e8f5-e063-6394a90ad25e1
866021cyproheptadine HCl 2 MG per 5 ML Oral SolutionSY50b3abc0-d86a-e8f5-e063-6394a90ad25e1
866021cyproheptadine HCl 4 MG per 10 ML Oral SyrupSY50b3abc0-d86a-e8f5-e063-6394a90ad25e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-504-4864980050448473 mL in 1 BOTTLE (64980-504-48) 473 ml2006-07-100000-00-00NoNoCurrent