Home NDC 16571-805 Cyproheptadine Hydrochloride
Product NDC 16571-805
11-digit product format 165710805
Labeler code 16571
Product ID 16571-805_93f4f73b-1ff4-4a64-a8ec-4a574abc3dd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cyproheptadine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA207555
Marketing category ANDA
Marketing start 2022-02-09
Substance CYPROHEPTADINE HYDROCHLORIDE
Active strength 4 mg/1
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 A207555-001 CYPROHEPTADINE HYDROCHLORIDE CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207555-001 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 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207555-001 CYPROHEPTADINE HYDROCHLORIDE 4MG TABLET / ORAL AA 2017-01-31 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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16571-805-01 Cyproheptadine Hydrochloride 100 in 1 BOTTLE TABLET 100 1 16571-805-10 Cyproheptadine Hydrochloride 1000 in 1 BOTTLE TABLET 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-805 CYPROHEPTADINE HYDROCHLORIDE TABLET [RISING PHARMA HOLDINGS, INC.] 1 Current NDC, Legacy NDC, 2 package rows 20220210_c5e9e983-d0d2-4f87-beae-0d853ca43983.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 16571-805-01 16571080501 100 TABLET in 1 BOTTLE (16571-805-01) 100 tablet 2022-02-10 0000-00-00 No No Current 16571-805-10 16571080510 1000 TABLET in 1 BOTTLE (16571-805-10) 1000 tablet 2022-02-10 0000-00-00 No No Current