Home NDC 0480-4000-62 Vestura
Product NDC 0480-4000
Requested package NDC 0480-4000-62
11-digit product format 004804000
Labeler code 0480
Product ID 0480-4000_894e556a-f100-4683-8c4a-3a0944fb96e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Drospirenone and Ethinyl Estradiol
Dosage form KIT
Labeler Teva Pharmaceuticals, Inc.
Application ANDA078833
Marketing category ANDA
Marketing start 2024-11-06
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 45 .
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 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL DROSPIRENONE; ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078833-001 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 · 45 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 2026-11-14 07:37:17 2026-10 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 d4dbc9d85df4…2026-10-15 13:18:30 2026-09 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 c2088c7a36db…2026-09-14 22:38:34 2026-08 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078833-001 DROSPIRENONE AND ETHINYL ESTRADIOL 3MG;0.02MG TABLET / ORAL AB 2011-11-28 3bdfa0b2c4d7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 45 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Vestura
Listing expiration 2027-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 630734 Internal RxNorm lookup 748797 Internal RxNorm lookup 748798 Internal RxNorm lookup 1233850 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 0480-3629-11 Vestura 24 in 1 BLISTER PACK TABLET 24 3 mg 2 0480-4000-28 Vestura 1 in 1 BLISTER PACK KIT 1 2 0480-4000-62 Vestura 3 in 1 CARTON KIT 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-4000 VESTURA (DROSPIRENONE AND ETHINYL ESTRADIOL) KIT [TEVA PHARMACEUTICALS, INC.] 1 Current NDC, 3 package rows 20241108_c6f63cc0-11b0-4320-a9ef-5bd5c9b16fd5.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0480-4000-62 00480400062 3 BLISTER PACK in 1 CARTON (0480-4000-62) / 1 KIT in 1 BLISTER PACK (0480-4000-28) * 24 TABLET in 1 BLISTER PACK (0480-3629-11) * 4 TABLET in 1 BLISTER PACK (0480-7892-22) 3 blister pack 2024-11-06 No No Current