FDA.reportPublic FDA data

Molindone Hydrochloride

Product NDC
42806-338
11-digit product format
428060338
Labeler code
42806
Product ID
42806-338_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
25 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090453-001MOLINDONE HYDROCHLORIDEMOLINDONE HYDROCHLORIDE5MGTABLET / ORAL2015-03-20
A090453-002MOLINDONE HYDROCHLORIDEMOLINDONE HYDROCHLORIDE10MGTABLET / ORAL2015-03-20
A090453-003MOLINDONE HYDROCHLORIDEMOLINDONE HYDROCHLORIDE25MGTABLET / ORALRS2015-03-20

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090453-001MOLINDONE HYDROCHLORIDE5MGTABLET / ORAL2015-03-20a50c72e98297…
2026-08-01 22:54:322026-06A090453-002MOLINDONE HYDROCHLORIDE10MGTABLET / ORAL2015-03-20a50c72e98297…
2026-08-01 22:54:322026-06A090453-003MOLINDONE HYDROCHLORIDE25MGTABLET / ORALRS2015-03-20a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Molindone HydrochlorideMOLINDONE HYDROCHLORIDEEPIC PHARMA, LLC1275e92f-9573-4d0c-8e77-1c9ac47696d22025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090453
application number: ANDA090453
ndc (product): 42806-338

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MOLINDONE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1DWS68PNE6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1298816Internal RxNorm lookup
1298906Internal RxNorm lookup
1298910Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1275e92f-9573-4d0c-8e77-1c9ac47696d2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a63697ab-3ea3-4b74-91f3-d075c914c513Product name120150420

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-338-01Molindone Hydrochloride100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-338-01EA - Each42806-338ab0f67f5-7c0d-4678-b958-d3a5421c609212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-338MOLINDONE HYDROCHLORIDE TABLET [EPIC PHARMA, LLC]3Current NDC, Legacy NDC, 1 package rows20231221_1275e92f-9573-4d0c-8e77-1c9ac47696d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298816molindone HCl 10 MG Oral TabletPSN1275e92f-9573-4d0c-8e77-1c9ac47696d25
1298906molindone HCl 25 MG Oral TabletPSN1275e92f-9573-4d0c-8e77-1c9ac47696d25
1298910molindone HCl 5 MG Oral TabletPSN1275e92f-9573-4d0c-8e77-1c9ac47696d25
1298816molindone hydrochloride 10 MG Oral TabletSCD1275e92f-9573-4d0c-8e77-1c9ac47696d25
1298906molindone hydrochloride 25 MG Oral TabletSCD1275e92f-9573-4d0c-8e77-1c9ac47696d25
1298910molindone hydrochloride 5 MG Oral TabletSCD1275e92f-9573-4d0c-8e77-1c9ac47696d25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-338-0142806033801100 TABLET in 1 BOTTLE (42806-338-01) 100 tablet2018-10-170000-00-00NoNoCurrent