FDA.reportPublic FDA data

NDC 50090-0653-01 - Phentermine Hydrochloride

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
50090-0653
Requested NDC
50090-0653-01
Package NDCs from labels
50090-0653-1, 50090-0653-2, 50090-0653-0, 50090-0653-01
Manufacturer
A-S Medication Solutions
Effective date
2026-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phentermine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2026-01-23HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-0653-02023-02-07These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-0653-12023-02-07These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-0653-22023-02-07These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-0653-02023-01-30These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-0653-12023-01-30These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959
50090-0653-22023-01-30These highlights do not include all the information needed to use Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg safely and effectively. See full prescribing information for Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg. Phentermine Hydrochloride Tablets and Capsules, USP 37.5 mg (phentermine hydrochloride, USP) CIV for oral use Initial U.S. Approval: 1959

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0653-0Phentermine Hydrochloride1000 in 1 BOTTLECAPSULE100029
50090-0653-1Phentermine Hydrochloride30 in 1 BOTTLECAPSULE3029
50090-0653-2Phentermine Hydrochloride28 in 1 BOTTLECAPSULE2829

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0653PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS]27Current NDC, Legacy NDC, 3 package rows20240215_ea798229-fc2d-417c-9bc9-a3b942f0b64b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0653-1EA - Each50090-0653f31a5a21-bf7b-41ab-affb-5f8488fcf5ef12018-10-11
50090-0653-2EA - Each50090-0653e2f0ca15-b738-4b34-9016-b88ca223c2f212018-10-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENTERMINE HYDROCHLORIDEACTIVE INGREDIENT0K2I505OTVPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
PHENTERMINEACTIVE MOIETYC045TQL4WPPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554PHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENTERMINE HYDROCHLORIDE TABLET PHENTERMINE HYDROCHLORIDE CAPSULE [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 6 of 107 · 2,130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackd95e14f7-a46d-47fa-8dab-ee3d8d4c7b6d2026-05-12Warnings, Adverse reactionsExact identifier
unii: 0K2I505OTV
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - DarkTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.aedde765-931f-430e-9fc3-d87bde2b78cd2026-05-12WarningsExact identifier
unii: 15FIX9V2JP
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - MediumTITANIUM DIOXIDE AND ZINC OXIDESENT, Inc.417305d7-d32e-4bc9-8f77-0a42b6bdecf52026-05-12WarningsExact identifier
unii: 15FIX9V2JP
The Perfect Derma Mineral Perfection Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEBella Medical Products LLC518f69fc-fd39-8195-e063-6294a90a3fdd2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
Radical Rescue Morning UVA/UVB Defense Primer Broad Spectrum SPF 30 Universal Tint Mineral SunscreenRADICAL RESCUE SPF 30 MINERAL SUNSCREENProTransit, Inc.38e0139c-bb87-55ba-e063-6294a90a82ee2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
EELHOE SunscreenTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5196ccb0-4515-7e40-e063-6394a90a09bd2026-05-11WarningsExact identifier
unii: 15FIX9V2JP
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke6939fcf-3db2-492a-99ed-a384cdeea7a22026-05-11Warnings, Adverse reactionsExact identifier
rxcui: 803353
unii: 0K2I505OTV
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 5.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbb65c8d7-318f-4d52-9d74-ca22ce3896382026-05-07WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior67b90f00-4c82-40cd-af96-f8dedf95f8af2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7a2bd17d-0ea7-4326-9939-a747869c01d22026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora396c0eb-f91f-4732-9c20-6b25aa0634b72026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior18b21fba-f6ee-4ac5-a536-096716f51da02026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior13c34bba-f939-4aa7-9457-9d6025902e062026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Diord12905b6-97aa-429a-8800-23856fe31f062026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior43599d17-81f4-4c6e-b6bd-d1e700b668ee2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 0.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior116f09db-f859-40c5-8857-33503903ee762026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior480e5bf9-8e24-4335-a434-93255ceb640e2026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7057feab-20fe-4547-8223-0816904bcfd62026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior672a804d-ba8e-4c03-91fc-3edc0b12c6272026-05-06WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 3.5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb656394d-a410-4f8c-a632-815a349fb17e2026-05-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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