Home NDC 42806-336 Molindone Hydrochloride
Product NDC 42806-336
11-digit product format 428060336
Labeler code 42806
Product ID 42806-336_d7c8ea49-c06c-441d-820e-def3920f7c1e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Molindone Hydrochloride
Dosage form TABLET
Route ORAL
Labeler EPIC PHARMA, LLC
Application ANDA090453
Marketing category ANDA
Marketing start 2018-10-17
Substance MOLINDONE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes Typical Antipsychotic [EPC]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090453-001 MOLINDONE HYDROCHLORIDE MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 A090453-002 MOLINDONE HYDROCHLORIDE MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 A090453-003 MOLINDONE HYDROCHLORIDE MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20
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 4 · 126 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 2026-08-18 06:07:40 2026-07 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090453-002 MOLINDONE HYDROCHLORIDE 10MG TABLET / ORAL 2015-03-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090453-003 MOLINDONE HYDROCHLORIDE 25MG TABLET / ORAL RS 2015-03-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090453-001 MOLINDONE HYDROCHLORIDE 5MG TABLET / ORAL 2015-03-20 1e350fbaab3a…
Additional Listing Data#
Finished product Yes
Brand name base Molindone Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MOLINDONE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1DWS68PNE6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1298816 Internal RxNorm lookup 1298906 Internal RxNorm lookup 1298910 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 42806-336-01 Molindone Hydrochloride 100 in 1 BOTTLE TABLET 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42806-336 MOLINDONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC] 3 Current NDC, Legacy NDC, 1 package rows 20231221_1275e92f-9573-4d0c-8e77-1c9ac47696d2.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 42806-336-01 42806033601 100 TABLET in 1 BOTTLE (42806-336-01) 100 tablet 2018-10-17 0000-00-00 No No Current