FDA.reportPublic FDA data

Drospirenone and ethinyl estradiol

Product NDC
75834-116
11-digit product format
758340116
Labeler code
75834
Product ID
75834-116_d14eb5b4-a0d0-4793-b41b-ab31bf2f16c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Drospirenone and ethinyl estradiol
Dosage form
KIT
Labeler
Nivagen Pharmaceuticals, Inc.
Application
ANDA202016
Marketing category
ANDA
Marketing start
2017-08-15
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11Product name420250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
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
94cad6dc-cea3-446b-a918-06fd714373a6Product name120211018
fa479cfe-0bd0-7366-d57a-92f3682e87c5Product name320210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9Product name320210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
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
89f15567-66a7-42ff-8abb-567b85d302d8Product name120190828
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
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
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
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
d0cc7d42-77a7-b452-c6c3-a162fa11225fProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75834-116-292025-01-30C16284748780-12cef2736-75f2-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS DROSPIRENONE and ETHINYL ESTRADIOL TABLETS, 3 mg/0.02 mg, for oral use Initial U.S. Approval:2001
75834-116-842025-01-30C16284748780-12cef2736-75f2-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS safely and effectively. See full prescribing information for DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS DROSPIRENONE and ETHINYL ESTRADIOL TABLETS, 3 mg/0.02 mg, for oral use Initial U.S. Approval:2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-116-29Drospirenone and ethinyl estradiol3 in 1 CARTONKIT33
75834-116-29Drospirenone and ethinyl estradiol1 in 1 BLISTER PACKKIT13
75834-116-84Drospirenone and ethinyl estradiol1 in 1 PACKETKIT13
75834-116-84Drospirenone and ethinyl estradiol1 in 1 BLISTER PACKKIT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-116-29EA - Each75834-1167de9fbb4-267c-402b-8963-bca286b3995812018-01-12
75834-116-84EA - Each75834-116f59c81cf-9c49-40c1-aefb-136c80c7676c12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-116DROSPIRENONE AND ETHINYL ESTRADIOL ( DROSPIRENONE AND ETHINYL ESTRADIOL ) KIT [NIVAGEN PHARMACEUTICALS, INC.]3Legacy NDC, 4 package rows20190911_ea2fdcc3-f453-45f6-ae34-1bf3a2766eb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
748798{24 (drospirenone 3 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 4 (inert ingredients 1 MG Oral Tablet) } PackGPCKea2fdcc3-f453-45f6-ae34-1bf3a2766eb73
748798Drospiren-Eth estra 3-0.02 MG (24) Oral Tablet / Inert 1 MG (4) Oral Tablet 28 Day PackPSNea2fdcc3-f453-45f6-ae34-1bf3a2766eb73
630734drospirenone 3 MG / ethinyl estradiol 0.02 MG Oral TabletPSNea2fdcc3-f453-45f6-ae34-1bf3a2766eb73
748797inert 1 MG Oral TabletPSNea2fdcc3-f453-45f6-ae34-1bf3a2766eb73
630734drospirenone 3 MG / ethinyl estradiol 0.02 MG Oral TabletSCDea2fdcc3-f453-45f6-ae34-1bf3a2766eb73
748797inert ingredients 1 MG Oral TabletSCDea2fdcc3-f453-45f6-ae34-1bf3a2766eb73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-116-29758340116293 BLISTER PACK in 1 CARTON (75834-116-29) > 1 KIT in 1 BLISTER PACK3 blister pack2017-08-150000-00-00NoNoCurrent
75834-116-84758340116841 BLISTER PACK in 1 PACKET (75834-116-84) > 1 KIT in 1 BLISTER PACK1 blister pack2017-08-150000-00-00NoNoCurrent