FDA.reportPublic FDA data

Nextstellis

Product NDC
51862-258
11-digit product format
518620258
Labeler code
51862
Product ID
51862-258_cb3d0738-1ec9-47a9-9167-8a4eb905ddab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
drospirenone and estetrol
Dosage form
KIT
Labeler
Mayne Pharma
Application
NDA214154
Marketing category
NDA
Marketing start
2021-04-16
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nextstellis
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui748797, 2539032, 2539033, 2539036

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94cad6dc-cea3-446b-a918-06fd714373a6Product name120211018
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9Product name820200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6Product name820191120
89f15567-66a7-42ff-8abb-567b85d302d8Product name120190828
ddff2484-d547-4e6a-bacd-95eef7e31c64Product name220180807
90854981-3820-4bc4-a1d3-666ec508941cProduct name220180214
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51862-258-00Nextstellis1 in 1 BLISTER PACKKIT17
51862-258-00Nextstellis1 in 1 CARTONKIT17
51862-258-01Nextstellis1 in 1 BLISTER PACKKIT17
51862-258-01Nextstellis1 in 1 CARTONKIT17
51862-259-24Nextstellis24 in 1 BLISTER PACKTABLET, FILM COATED243 mg7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-258-01EA - Each51862-258a21ed1b0-ece1-457c-a558-81da2ae39be912021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-258NEXTSTELLIS (DROSPIRENONE AND ESTETROL) KIT [MAYNE PHARMA]7Current NDC, Legacy NDC, 5 package rows20230804_c5270073-d083-4109-ae4b-156986175e0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2539032{24 (drospirenone 3 MG / estetrol 14.2 MG Oral Tablet) / 4 (inert ingredients 1 MG Oral Tablet) } Pack [Nextstellis 28 Day]BPCKc5270073-d083-4109-ae4b-156986175e0a7
2539036{24 (drospirenone 3 MG / estetrol 14.2 MG Oral Tablet) / 4 (inert ingredients 1 MG Oral Tablet) } PackGPCKc5270073-d083-4109-ae4b-156986175e0a7
2539036drospiren-estetrol 3-14.2 MG (24) Oral Tablet / Inert 1 MG (4) Oral Tablet 28 Day PackPSNc5270073-d083-4109-ae4b-156986175e0a7
2539033drospirenone 3 MG / estetrol 14.2 MG Oral TabletPSNc5270073-d083-4109-ae4b-156986175e0a7
748797inert 1 MG Oral TabletPSNc5270073-d083-4109-ae4b-156986175e0a7
2539032Nextstellis 28 Day PackPSNc5270073-d083-4109-ae4b-156986175e0a7
2539033drospirenone 3 MG / estetrol 14.2 MG Oral TabletSCDc5270073-d083-4109-ae4b-156986175e0a7
748797inert ingredients 1 MG Oral TabletSCDc5270073-d083-4109-ae4b-156986175e0a7
2539032Nextstellis 28 Day PackSYc5270073-d083-4109-ae4b-156986175e0a7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-258-00518620258001 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) 1 blister pack2021-04-160000-00-00YesNoCurrent
51862-258-01518620258011 BLISTER PACK in 1 CARTON (51862-258-01) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) 1 blister pack2021-04-160000-00-00NoNoCurrent
51862-259-245186202592424 in 1 BLISTER PACKHistorical