Home NDC 63629-2449 Volnea
Product NDC 63629-2449
11-digit product format 636292449
Labeler code 63629
Product ID 63629-2449_50ece9ce-fedb-4a45-9ac6-e4253fcab02c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desogestrel and Ethinyl Estradiol
Dosage form KIT
Labeler Bryant Ranch Prepack
Application ANDA202689
Marketing category ANDA
Marketing start 2017-12-01
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 42 .
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 A202689-001 VOLNEA DESOGESTREL; ETHINYL ESTRADIOL 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202689-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202689-001 VOLNEA 0.15MG,N/A;0.02MG,0.01MG TABLET / ORAL-28 AB 2016-09-09 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Volnea
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 248310 Internal RxNorm lookup 249357 Internal RxNorm lookup 748797 Internal RxNorm lookup 759743 Internal RxNorm lookup 2001756 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 63629-2449-1 Volnea 1 in 1 BLISTER PACK KIT 1 103 63629-2449-1 Volnea 3 in 1 CARTON KIT 3 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2449 VOLNEA (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [BRYANT RANCH PREPACK] 103 Current NDC, Legacy NDC, 2 package rows 20240112_0e65209d-329a-4d31-8afb-24348dc8d7e7.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 · 2 matching rows.
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 63629-2449-1 63629244901 3 BLISTER PACK in 1 CARTON (63629-2449-1) / 1 KIT in 1 BLISTER PACK 3 blister pack 2021-04-27 0000-00-00 No No Current