Home NDC 50419-402 Yasmin
Product NDC 50419-402
11-digit product format 504190402
Labeler code 50419
Product ID 50419-402_84c4a6e5-8157-4f6d-a51f-3665e8568a3c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name drospirenone and ethinyl estradiol
Dosage form KIT
Labeler Bayer HealthCare Pharmaceuticals Inc.
Application NDA021098
Marketing category NDA
Marketing start 2001-05-11
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021098-001 YASMIN DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021098-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021098-001 YASMIN 3MG;0.03MG TABLET / ORAL-28 AB RLD, RS 2001-05-11 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021098-001 6787531 2020-08-31 Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021098-001 6787531 2020-08-31 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021098-001 6787531 2020-08-31 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021098-001 6787531 2020-08-31 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021098-001 6787531 2020-08-31 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021098-001 6787531 2020-08-31 Drug product ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Yasmin
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 284207 Internal RxNorm lookup 748797 Internal RxNorm lookup 748800 Internal RxNorm lookup 748857 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50419-402-03 Yasmin 3 in 1 PACKAGE KIT 3 21 50419-402-03 Yasmin 1 in 1 BLISTER PACK KIT 1 21
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DROSPIRENONE ACTIVE INGREDIENT N295J34A25 YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 DROSPIRENONE ACTIVE MOIETY N295J34A25 YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 POVIDONE K25 INACTIVE INGREDIENT K0KQV10C35 YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 10 DROSPIRENONE ACTIVE INGREDIENT N295J34A25 YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2 ETHINYL ESTRADIOL ACTIVE INGREDIENT 423D2T571U YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2 DROSPIRENONE ACTIVE MOIETY N295J34A25 YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2 ETHINYL ESTRADIOL ACTIVE MOIETY 423D2T571U YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2 POVIDONE K25 INACTIVE INGREDIENT K0KQV10C35 YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [PHYSICIANS TOTAL CARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50419-402 YASMIN (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] 21 Current NDC, Legacy NDC, 2 package rows 20241122_d7ea6a60-5a56-4f81-b206-9b27b7e58875.zip
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 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Yasmin DROSPIRENONE AND ETHINYL ESTRADIOL Bayer HealthCare Pharmaceuticals Inc. d7ea6a60-5a56-4f81-b206-9b27b7e58875 2023-05-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021098 application number: NDA021098 ndc (product): 50419-402
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50419-402-03 50419040203 3 BLISTER PACK in 1 PACKAGE (50419-402-03) / 1 KIT in 1 BLISTER PACK 3 blister pack 2001-05-11 0000-00-00 No No Current