FDA.reportPublic FDA data

NDC 0603-7663-01 - Tri-Previfem

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
0603-7663
Requested NDC
0603-7663-01
Package NDCs from labels
0603-7663-01, 0603-7663-17
Manufacturer
RPK Pharmaceuticals, Inc.
Effective date
2018-09-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tri-Previfem - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2018-09-13HUMAN PRESCRIPTION DRUG LABEL
Previfem - Par Pharmaceutical | Patheon Inc. | Sharp CorporationPar Pharmaceutical | Patheon Inc. | Sharp Corporation2017-08-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-7663-01EA - Each0603-7663b921e1c5-b45f-4237-b210-db101f91642012015-05-05
0603-7663-17EA - Each0603-766380de8baa-301c-4ca5-bd1e-5e62a280e66d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
NORGESTIMATEACTIVE MOIETYC291HFX4DYPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREVIFEM (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]12

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 10 · 185 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NuvaRingETONOGESTREL AND ETHINYL ESTRADIOLAdvanz Pharma (US) Corp.19ef66d1-913f-49a8-a0a5-59b4e20322f52025-03-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.8b82ad14-580c-4145-b825-dce849f953632025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLPrasco Laboratoriesf0d80e01-f4f5-4b1a-bc9e-50a2bd4390b12025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Loestrin Fe 28 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATETeva Women's Health LLCf29ebcb5-7e65-4092-bfaa-f5ec026fc2552025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
LUIZZA 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed LLCb1c3e33d-ec95-cd89-7ad9-36994c802a1f2025-02-12Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Code Red Eye Drops Redness ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL4 Trees, LLC0aa08018-cc2d-d947-e063-6394a90a914a2025-02-07WarningsExact identifier
unii: B697894SGQ
EluRyngETONOGESTREL AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLCc6c8512d-b258-4be5-8c2f-0f1893f198b92025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: B697894SGQ
Glitch Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLMisemer Pharmaceutical, Inc03778509-3374-2168-e063-6294a90a95052024-12-23WarningsExact identifier
unii: B697894SGQ
Junel 21 DayNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLProficient Rx LP56e91ad4-f31b-494d-9e75-6dd4f396779c2024-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Kenvue Brands LLCa9a90de6-3172-4d34-984b-f4442f880e3d2024-11-13WarningsExact identifier
unii: B697894SGQ
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLC2de7a41d-661d-495f-89b4-5690664a3a3d2024-11-13WarningsExact identifier
unii: B697894SGQ
Visine Dry Eye Relief Eye DropsPOLYETHYLENE GLYCOL 400Kenvue Brands LLCd9d3f000-3ce4-4ba2-a7fb-491b44eb3fa12024-11-13WarningsExact identifier
unii: B697894SGQ
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLCa4c57620-778f-4434-9105-ead2f85c58842024-11-13WarningsExact identifier
unii: B697894SGQ
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated10fcf407-6eaf-4730-9ed0-9b7715cf57012024-09-20WarningsExact identifier
unii: B697894SGQ
blink gel tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated6f7e06c3-204d-459a-af8f-c46be9ad0e8d2024-09-20WarningsExact identifier
unii: B697894SGQ
Leader Preservative-Free Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Health2a2aa620-ca63-4698-88fd-fc263b8fa0d12024-09-07WarningsExact identifier
unii: B697894SGQ
Etonogestrel and Ethinyl Estradiol Vaginal RingETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RINGNorthstar Rx LLC1488f5ae-3b34-fcd7-6049-215929b1d3242024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
EnilloRingETONOGESTREL AND ETHINYL ESTRADIOL VAGINALXiromed, LLC85a126f6-d3e0-9e12-73f9-6176ba36f58b2024-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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