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 1 of 18 · 359 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Etonogestrel and Ethinyl Estradiol VaginalETONOGESTREL AND ETHINYL ESTRADIOL VAGINALAvKARE05e172aa-e18a-427b-e063-6294a90ae22f2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
SprintecNORGESTIMATE AND ETHINYL ESTRADIOLPreferred Pharmaceuticals, Inc.90240210-0bca-4a55-99dc-19f2b40d8e3f2026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SLYNDDROSPIRENONEExeltis USA, Inc.db32bc55-f295-4d87-9dbb-0a2f45573dcf2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 748797
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: B697894SGQ
IsibloomDESOGESTREL AND ETHINYL ESTRADIOLBryant Ranch Prepack4a8f278f-f505-4537-8deb-74e8927df8c62026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
EstaryllaNORGESTIMATE AND ETHINYL ESTRADIOLBryant Ranch Prepacke0b07fb6-8dbd-4e5d-b589-5191a1dc02ae2026-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: B697894SGQ
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: B697894SGQ
DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE AND ETHINYL ESTRADIOLRedpharm Drug57d1d945-9fc9-4e79-e063-6294a90a738a2026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
norgestimate and ethinyl estradiolNORGESTIMATE AND ETHINYL ESTRADIOLPD-Rx Pharmaceuticals, Inc.2385591b-70ee-0577-e063-6394a90a93572026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
TwirlaLEVONORGESTREL/ETHINYL ESTRADIOLAgile Therapeutics, Inc.bcaf8db0-1750-425d-b008-255b5e7a9cc62026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 423D2T571U
Desogestrel and Ethinyl EstradiolDESOGESTREL AND ETHINYL ESTRADIOLCamber Pharmaceuticals, Inc.78454ebf-f1a3-4ca0-b32e-88c51bc577732026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
VIORELEDESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOLA-S Medication Solutions6422dcc3-959a-4590-9ca8-9dcb58e682532026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
MONO-LINYAHNORGESTIMATE AND ETHINYL ESTRADIOLA-S Medication Solutions2ec8f18f-297c-405f-b191-a40767366bad2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
unii: B697894SGQ
VitaPhyte Redness Reliever Lubricant Eye DropsREDNESS RELIEVER LUBRICANT EYE DROPSGuangzhou Liyan Cosmetics Technology Co., Ltd.53d4e9b0-c9a0-797a-e063-6294a90ad0cf2026-06-04WarningsExact identifier
unii: B697894SGQ
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
unii: B697894SGQ
Blink Triple Care Preservative FreePOLYETHYLENE GLYCOL 400Bausch & Lomb Incorporated65e67990-78b7-4ce9-963b-6bed3a6bed072026-05-27WarningsExact identifier
unii: B697894SGQ
TurqozNORGESTREL AND ETHINYL ESTRADIOLA-S Medication Solutionse7a05138-91a5-4c66-a915-614576e0805a2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 748797

Reported adverse events (FAERS/openFDA)#

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