FDA.reportPublic FDA data

NDC 0603-7521-01 - Cyclafem 1/35

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
0603-7521
Requested NDC
0603-7521-01
Package NDCs from labels
0603-7521-01, 0603-7521-49, 0603-7521-17
Manufacturer
RPK Pharmaceuticals, Inc.
Effective date
2020-12-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyclafem™ 1/35 (norethindrone and ethinyl estradiol tablets USP)RPK Pharmaceuticals, Inc.2020-12-15HUMAN PRESCRIPTION DRUG LABEL
Cyclafem 1/35 - Par Pharmaceutical, Inc. | Patheon Inc. | Sharp CorporationPar Pharmaceutical, Inc. | Patheon Inc. | Sharp Corporation2018-06-06HUMAN PRESCRIPTION DRUG LABEL
Cyclafem 1/35 - Central Texas Community Health CentersCentral Texas Community Health Centers2016-01-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-7521-01EA - Each0603-752191fc3d55-4cc2-44c0-ac34-3f206c62952312015-05-05
0603-7521-17EA - Each0603-75213ad688f4-734c-4aeb-ad21-82df52f6a57c12012-07-24
0603-7521-49EA - Each0603-7521bde89cca-26b9-4178-9277-bf6955e4573912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
NORETHINDRONEACTIVE INGREDIENTT18F433X4SCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
NORETHINDRONEACTIVE MOIETYT18F433X4SCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCYCLAFEM 1/35 (NORETHINDRONE AND ETHINYL ESTRADIOL) KIT [QUALITEST PHARMACEUTICALS]11

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 2 of 18 · 359 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KurveloLEVONORGESTREL AND ETHINYL ESTRADIOLLupin Pharmaceuticals, Inc.752f525e-1838-4058-9ab7-2c2d91f86dfd2026-05-20Boxed warning, WarningsExact identifier
rxcui: 748797
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLApotex Corp.9187a357-e95d-4733-9627-f19522b863732026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
blink tearsPOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporatedf1d07347-086f-43b2-aa5f-910764fc666e2026-05-13WarningsExact identifier
unii: B697894SGQ
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: B697894SGQ
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Pharmaceuticals USA Inc.10fa1458-c8ed-4197-922a-1ba7271d2b022026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
norelgestromin and ethinyl estradiolNORELGESTROMIN AND ETHINYL ESTRADIOLZydus Lifesciences Limited7c2cc8ab-db6d-4a1c-ae74-e0ef27e2f3a92026-04-16Exact identifier
unii: 423D2T571U
WeraNORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLC638e4f36-1a27-4220-8ec9-3fa9d9b36c112026-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Dasetta 7/7/7NORETHINDRONE AND ETHINYL ESTRADIOLNorthstar Rx LLCda52e74a-1baf-4a33-a068-b491767003202026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
rxcui: 312033
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: B697894SGQ
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
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: B697894SGQ
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

Reported adverse events (FAERS/openFDA)#

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