FDA.reportPublic FDA data

Norgestimate and Ethinyl Estradiol

Product NDC
53002-1732
11-digit product format
530021732
Labeler code
53002
Product ID
53002-1732_eab40804-b591-4a81-b6e7-a0358db965d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Norgestimate and Ethinyl Estradiol
Dosage form
KIT
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA200538
Marketing category
ANDA
Marketing start
2012-04-06
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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8511fc19-172b-4e1f-90ec-2f09c85b16deProduct name220250116
d9a998ac-31a9-4391-9054-c30e50912603Product name220240829
782f1593-b73e-4d35-8017-647969d714d8Product name420240805
1a545a57-aed5-4b6e-b1f9-a93c26d50effProduct name120230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50Product name320230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689Product name520230627
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
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00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
5956a0e2-c373-452c-bdcf-c93d354432efProduct name120200714
ca306105-d51c-4821-9ec1-8eec753d073dProduct name120200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9Product name820200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
6dd982ab-2966-22ee-3b75-d225abb791aaProduct name520190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4dProduct name720190612
f92411e4-13dd-7baf-106e-9b3fcf758c39Product name420190502
60ff9adc-7870-42ca-8836-514bd9732fa8Product name420181220
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
79d5025d-8129-440a-b861-6df2d2661609Product name320180607
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
d871c48c-6b0b-4203-b55d-72ead21ea7adProduct name520180419
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
12434b90-2738-45d5-9e1b-55001e853273Product name220171122
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3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
2d386545-84d1-e1e9-1402-7fc8962353e8Product name220170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8Product name420170608
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
120cc5ad-761c-444c-9e82-dec22f96dfe1Product name720161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-1732-12025-01-30C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-32025-01-30C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-62025-01-30C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-12023-06-07C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-32023-06-07C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-62023-06-07C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-12023-01-30C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-32023-01-30C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-62023-01-30C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-12020-12-16C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-32020-12-16C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-62020-12-16C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-12020-01-31C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-32020-01-31C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989
53002-1732-62020-01-31C16284748780-19d75b9cf-e0ba-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS. NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.25 mg/0.035 mg, for oral use NORGESTIMATE and ETHINYL ESTRADIOL tablets, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1732-1Norgestimate and Ethinyl Estradiol1 in 1 PACKAGEKIT15
53002-1732-1Norgestimate and Ethinyl Estradiol1 in 1 BLISTER PACKKIT15
53002-1732-3Norgestimate and Ethinyl Estradiol1 in 1 BLISTER PACKKIT15
53002-1732-3Norgestimate and Ethinyl Estradiol3 in 1 PACKAGEKIT35
53002-1732-6Norgestimate and Ethinyl Estradiol6 in 1 PACKAGEKIT65
53002-1732-6Norgestimate and Ethinyl Estradiol1 in 1 BLISTER PACKKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1732NORGESTIMATE AND ETHINYL ESTRADIOL KIT [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 6 package rows20230609_3e8149e1-ada2-4f3d-996b-466759cbb344.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749860{21 (ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } PackGPCK3e8149e1-ada2-4f3d-996b-466759cbb3445
749860Eth estra-Norgestim 0.035-0.25 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day PackPSN3e8149e1-ada2-4f3d-996b-466759cbb3445
748797inert 1 MG Oral TabletPSN3e8149e1-ada2-4f3d-996b-466759cbb3445
240128norgestimate 0.25 MG / ethinyl estradiol 0.035 MG Oral TabletPSN3e8149e1-ada2-4f3d-996b-466759cbb3445
240128ethinyl estradiol 0.035 MG / norgestimate 0.25 MG Oral TabletSCD3e8149e1-ada2-4f3d-996b-466759cbb3445
748797inert ingredients 1 MG Oral TabletSCD3e8149e1-ada2-4f3d-996b-466759cbb3445
240128ethinyl estradiol 35 MCG / norgestimate 0.25 MG Oral TabletSY3e8149e1-ada2-4f3d-996b-466759cbb3445

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1732-1530021732011 BLISTER PACK in 1 PACKAGE (53002-1732-1) > 1 KIT in 1 BLISTER PACK1 blister pack2017-09-010000-00-00NoNoCurrent
53002-1732-3530021732033 BLISTER PACK in 1 PACKAGE (53002-1732-3) > 1 KIT in 1 BLISTER PACK3 blister pack2017-09-010000-00-00NoNoCurrent
53002-1732-6530021732066 BLISTER PACK in 1 PACKAGE (53002-1732-6) > 1 KIT in 1 BLISTER PACK6 blister pack2017-09-010000-00-00NoNoCurrent