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 9 of 10 · 186 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: B697894SGQ
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
unii: B697894SGQ
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
unii: 3NXW29V3WO
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.db3a6c68-320b-46b0-83fa-6c29297a84a62023-12-15WarningsExact identifier
unii: B697894SGQ
SystanePOLYETHYLENE GLYCOL AND PROPYLENE GLYCOLAlcon Research Ltd14916d2c-a63d-491e-bd91-a61f300af38a2023-12-15WarningsExact identifier
unii: B697894SGQ
Systane LubricantPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.15bc06ec-f3dc-3180-ca1a-106769a770ea2023-12-15WarningsExact identifier
unii: B697894SGQ
Systane ULTRAPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.a5c1c194-3db5-4f18-9cd1-97f7f84c3cff2023-12-15WarningsExact identifier
unii: B697894SGQ
GenTeal Tears Gel DropsPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.84388a75-9d11-48ce-bf5a-88f0580d2d032023-12-14WarningsExact identifier
unii: B697894SGQ
Etonogestrel/Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsfcf9da2a-bb91-4697-bfaa-c9d58855e2752023-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Aurovela 1.5/30NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limitedb146e49c-a0fc-4f3d-9ad6-99e8257fa1392023-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Aurovela 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLAurobindo Pharma Limited6765becf-7b51-4f33-ac13-70fcd01decf72023-11-21Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: B697894SGQ
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: B697894SGQ
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: B697894SGQ
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: H3R47K3TBD
Etonogestrel and Ethinyl EstradiolETONOGESTREL AND ETHINYL ESTRADIOLTeva Pharmaceuticals USA, Inc.a8cc104a-d522-49ad-af54-2f312b829b612022-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
ZAFEMYNORELGESTROMIN AND ETHINYL ESTRADIOLAmneal Pharmaceuticals LLC5ee34c07-65af-42b8-a98f-e299ff90a8a12022-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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