Home NDC 27808-099 Cyproheptadine Hydrochloride
Product NDC 27808-099
11-digit product format 278080099
Labeler code 27808
Product ID 27808-099_33793609-a343-4194-8417-247b70b514de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyproheptadine Hydrochloride
Dosage form SYRUP
Route ORAL
Labeler Tris Pharma Inc
Application ANDA205431
Marketing category ANDA
Marketing start 2021-12-21
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 A205431-001 CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21
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.
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 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA 2021-12-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA 2021-12-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL AA 2021-12-21 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A205431-001 CYPROHEPTADINE HYDROCHLORIDE 2MG/5ML SYRUP / ORAL 2021-12-21 a50c72e98297…
Observed Orange Book normalized TE history# 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 27808-099-01 Cyproheptadine Hydrochloride 473 mL in 1 BOTTLE, PLASTIC SYRUP 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27808-099 CYPROHEPTADINE HYDROCHLORIDE SYRUP [TRIS PHARMA INC] 2 Current NDC, Legacy NDC, 1 package rows 20220316_2b438746-14c2-44ef-a127-62b8d2efdc55.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 · 1 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 27808-099-01 27808009901 473 mL in 1 BOTTLE, PLASTIC (27808-099-01) 473 ml 2022-12-30 0000-00-00 No No Current