FDA.reportPublic FDA data

NDC 0603-7642-01 - 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
0603-7642
Requested NDC
0603-7642-01
Package NDCs from labels
0603-7642-01, 0603-7642-17
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
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
Previfem - Central Texas Community Health CentersCentral Texas Community Health Centers2016-12-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-7642-01EA - Each0603-76420d8c601b-feb4-460f-aea5-b66acb5ffe8e12015-05-05
0603-7642-17EA - Each0603-76421de86e5b-ad41-4354-941a-c77a5a77510512012-07-24

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 18 · 359 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foster and Thrive Lubricating Tears Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC0042337b-c22a-157a-e063-6394a90a202e2025-12-30WarningsExact identifier
unii: B697894SGQ
CVS Lubricant Eye Drops OriginalPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVSbb1ad35a-79ea-639f-e053-2995a90a96f32025-12-30WarningsExact identifier
unii: B697894SGQ
Foster and Thrive Advanced Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCLStrategic Sourcing Services LLC0019cd99-b245-2ffc-e063-6294a90a9f272025-12-30WarningsExact identifier
unii: B697894SGQ
CVS Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATECVS Pharmacy, Inc.be3d7855-cc66-ace8-e053-2a95a90ab8f42025-12-30WarningsExact identifier
unii: B697894SGQ
Foster and Thrive Dry Eye ReliefPOLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC0018ade9-5856-db6c-e063-6394a90a2ccf2025-12-30WarningsExact identifier
unii: B697894SGQ
Foster and Thrive Long Lasting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC00546df0-17d8-0e3c-e063-6294a90ae7b22025-12-30WarningsExact identifier
unii: B697894SGQ
Meijer Multi-Symptom ReliefPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEMeijer, Inc.e7a5677a-ff33-c039-e053-2a95a90ae6c72025-12-30WarningsExact identifier
unii: B697894SGQ
Avenova Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLNovaBay Pharmaceuticals, Inc.cd17f037-5aa5-0ef8-e053-2a95a90a39cb2025-12-30WarningsExact identifier
unii: B697894SGQ
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalmart, Inc.deebaf7f-f20d-4d7f-e053-2a95a90a4b4f2025-12-30WarningsExact identifier
unii: B697894SGQ
Equate Multi-Symptom Relief Eye DropsPOLYETHYLENE GLYCOL 400,TETRAHYDROZOLINE HCL, ZINC SULFATEWalmart, Inc.eb8ed76b-9cd7-3636-e053-2a95a90a95832025-12-30WarningsExact identifier
unii: B697894SGQ
CorneaCare Recover Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCorneaCare Inc.1fd3a5ed-8963-5c8e-e063-6394a90a65272025-12-30WarningsExact identifier
unii: B697894SGQ
Quality Choice Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd1b36a-a07a-a1db-e063-6294a90a59942025-12-30WarningsExact identifier
unii: B697894SGQ
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: B697894SGQ
Quality Choice Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd91c45-88a2-f88c-e063-6294a90ad1272025-12-30WarningsExact identifier
unii: B697894SGQ
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
unii: B697894SGQ
Equaline Multi-Symptom Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEUnited Natural Foods, Inc.fe467606-6d66-b695-e053-6294a90aab5d2025-12-30WarningsExact identifier
unii: B697894SGQ
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
unii: B697894SGQ
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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