FDA.reportPublic FDA data

NDC 50090-0120-05 - Diethylpropion Hydrochloride ER

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50090-0120
Requested NDC
50090-0120-05
Package NDCs from labels
50090-0120-1, 50090-0120-5, 50090-0120-0, 50090-0120-4, 50090-0120-05
Manufacturer
A-S Medication Solutions
Effective date
2026-05-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diethylpropion Hydrochloride ER - A-S Medication SolutionsA-S Medication Solutions2026-05-29HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-0120-02023-02-07Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-02023-02-07Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-12023-02-07Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-12023-02-07Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-42023-02-07Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-42023-02-07Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-52023-02-07Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-52023-02-07Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-02023-01-30Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-02023-01-30Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-12023-01-30Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-12023-01-30Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-42023-01-30Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-42023-01-30Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-52023-01-30Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only
50090-0120-52023-01-30Diethylpropion Hydrochloride Extended Release Tablets, 75 mg CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0120-0Diethylpropion HydrochlorideER30 in 1 BOTTLETABLET, EXTENDED RELEASE3027
50090-0120-1Diethylpropion HydrochlorideER15 in 1 BOTTLETABLET, EXTENDED RELEASE1527
50090-0120-4Diethylpropion HydrochlorideER7 in 1 BOTTLETABLET, EXTENDED RELEASE727
50090-0120-5Diethylpropion HydrochlorideER28 in 1 BOTTLETABLET, EXTENDED RELEASE2827

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0120DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]27Current NDC, Legacy NDC, 4 package rows20230306_04f1a804-00f1-48f5-acfa-0ed1a8544784.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0120-0EA - Each50090-01201e72a94c-f781-42e9-94ab-f977ef5c4f7112021-05-05
50090-0120-5EA - Each50090-012060efe552-bbc6-4dd7-a622-8c7369491a7012021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIETHYLPROPION HYDROCHLORIDEACTIVE INGREDIENT19V2PL39NGDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
DIETHYLPROPIONACTIVE MOIETYQ94YYU22B8DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
CARBOMER HOMOPOLYMER TYPE AINACTIVE INGREDIENTF68VH75CJCDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)INACTIVE INGREDIENT6N003M473WDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ADIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HDIETHYLPROPION HYDROCHLORIDE ER (DIETHYLPROPION HYDROCHLORIDE) TABLET, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1

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 2 · 37 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEA-S Medication Solutions04f1a804-00f1-48f5-acfa-0ed1a85447842026-05-29Warnings, Adverse reactionsExact identifier
application number: ANDA091680
ndc (package): 50090-0120-1
ndc (package): 50090-0120-5
ndc (package): 50090-0120-4
ndc (package): 50090-0120-0
ndc (product): 50090-0120
ndc11 (package): 50090012005
rxcui: 978668
spl id: d981b5d1-223d-4024-979d-562213dc95f0
spl set id: 04f1a804-00f1-48f5-acfa-0ed1a8544784
unii: 19V2PL39NG
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Joint Tonic R IIHARPAGOPHYTUM PROCUMBENS, SALIX ALBA, COLCHICUM AUTUMNALE, PINUS SYLVESTRIS, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARNICA MONTANA, GELSEMIUM SEMPERVIRENS, IRIS VERSICOLOR, LEDUM PALUSTRE, LESPEDEZA CAPITATA, RHUS TOX, SECALE CORNUTUM, SPIGELIA ANTHELMIA, SPIRAEA ULMARIA, TARTARICUM ACIDUMBioActive Nutritional, Inc.77afccf5-4e9c-45a1-8a6a-e686bcf22f162026-04-17WarningsExact identifier
unii: W4888I119H
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ad0c3dc9-ae13-4853-bc8c-a66e2a69cc102025-10-15Warnings, Adverse reactionsExact identifier
unii: 19V2PL39NG
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0d213a24-ebbf-41df-8f32-de44a572829e2025-10-15Warnings, Adverse reactionsExact identifier
application number: ANDA091680
rxcui: 978668
unii: 19V2PL39NG
Diethylpropion HydrochlorideDIETHYLPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5777eed8-c63d-49c4-9dd1-9d087906c3682025-10-02Warnings, Adverse reactionsExact identifier
unii: 19V2PL39NG
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEOMNIVIUM PHARMACEUTICALS LLC.cd4f2b19-8752-4fed-81f3-d3074ade613c2025-09-19Warnings, Adverse reactionsExact identifier
application number: ANDA091680
rxcui: 978668
unii: 19V2PL39NG
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEMartek Pharmacal Co.130511dc-8f01-02ca-e063-6394a90a671b2025-07-21Warnings, Adverse reactionsExact identifier
unii: 19V2PL39NG
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: W4888I119H
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.335fb85d-8b1f-e648-e063-6294a90aa1582025-04-22Warnings, Adverse reactionsExact identifier
unii: 19V2PL39NG
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDENuCare Pharmaceuticals, Inc.335265e0-1d5d-31fb-e063-6394a90a2e752025-04-21Warnings, Adverse reactionsExact identifier
application number: ANDA091680
rxcui: 978668
unii: 19V2PL39NG
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDECalvin Scott & Co., Inc.fa48ad75-4fc8-4355-a19d-cd1b9d87f5532025-02-27Warnings, Adverse reactionsExact identifier
unii: 19V2PL39NG
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDECalvin Scott & Co., Inc.d6cde8cc-26ae-4087-8eac-b11192749cc52025-02-25Warnings, Adverse reactionsExact identifier
application number: ANDA091680
rxcui: 978668
unii: 19V2PL39NG

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.