Home NDC 64980-504 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040668-001 CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040668-001 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 RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040668-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA RS 2006-06-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64980-504-48 Cyproheptadine Hydrochloride 473 mL in 1 BOTTLE SYRUP 473 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CYPROHEPTADINE HYDROCHLORIDE ACTIVE INGREDIENT NJ82J0F8QC CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.] 4 CYPROHEPTADINE ACTIVE MOIETY 2YHB6175DO CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.] 4 ALCOHOL INACTIVE INGREDIENT 3K9958V90M CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.] 4 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.] 4 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.] 4 SORBIC ACID INACTIVE INGREDIENT X045WJ989B CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMACEUTICALS, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-504 CYPROHEPTADINE HYDROCHLORIDE SYRUP [RISING PHARMA HOLDINGS, INC.] 9 Current NDC, Legacy NDC, 1 package rows 20250402_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64980-504-48 64980050448 473 mL in 1 BOTTLE (64980-504-48) 473 ml 2006-07-10 0000-00-00 No No Current