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 3 of 18 · 359 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Norethindrone Acetate and Ethinyl EstradiolNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLA-S Medication Solutions38924c83-53aa-4279-8f0e-1a5d8f5fd8ad2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
VesturaDROSPIRENONE AND ETHINYL ESTRADIOLTeva Pharmaceuticals, Inc.c6f63cc0-11b0-4320-a9ef-5bd5c9b16fd52026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
BLINK TRIPLE CAREPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporateda2b34eb0-001b-4f42-a8cc-c2a0150fafcc2026-03-20WarningsExact identifier
unii: B697894SGQ
Junel FEJUNEL FEDirect_Rxea62a66e-d45d-11be-e053-2a95a90a78012026-03-17Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: B697894SGQ
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: B697894SGQ
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: B697894SGQ
unii: 3NXW29V3WO
CryselleNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsf73ece43-6b5f-4abb-ba6d-4d62775f2f8e2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions35c6507c-555a-45ed-aaf6-8695831de71a2026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749860
rxcui: 240128
VIENVA TMLEVONORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionsf6825c1a-ba78-47aa-9622-12e59517ab1a2026-03-03Warnings, Adverse reactionsExact identifier
rxcui: 748797
drospirenone and ethinyl estradiolDROSPIRENONE AND ETHINYL ESTRADIOLA-S Medication Solutions6edead7f-a41f-4d0b-a27a-b2047ed4eea02026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
LuteraLEVONORGESTREL AND ETHINYL ESTRADIOLDr. Reddys Laboratories Inc.47fc432b-2259-47d2-bba9-5e3aae5839902026-02-13Warnings, Adverse reactionsExact identifier
rxcui: 748797
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: B697894SGQ
Norgestimate and Ethinyl EstradiolNORGESTIMATE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA8b247e46-203e-4f5b-b5a7-cbd57341c7352026-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 749860
rxcui: 240128
BRIELLYNNORETHINDRONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USAc0e2c5b4-70ac-4b41-aa71-00e506dbb72f2026-01-31Warnings, Adverse reactionsExact identifier
rxcui: 748797
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA39988aa6-8f68-40e8-9bdd-c40a3bdaad612026-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
ALYACEN 1/35NORETHINDRONE AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA5c02b4d3-1e2f-439a-ae45-02304ee190d12026-01-31Warnings, Adverse reactionsExact identifier
rxcui: 748797
Levonorgestrel and Ethinyl EstradiolLEVONORGESTREL AND ETHINYL ESTRADIOLGlenmark Pharmaceuticals Inc., USA44fbc5ae-5682-471f-a12a-955e8b4d233a2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U

Reported adverse events (FAERS/openFDA)#

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