Home NDC 63629-2344 Vienva TM
Product NDC 63629-2344
11-digit product format 636292344
Labeler code 63629
Product ID 63629-2344_ca7fde3e-fc33-4471-8d4b-7aeec6545d4d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Levonorgestrel and Ethinyl Estradiol
Dosage form KIT
Labeler Bryant Ranch Prepack
Application ANDA201088
Marketing category ANDA
Marketing start 2018-03-15
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 A201088-001 VIENVA ETHINYL ESTRADIOL; LEVONORGESTREL 0.02MG;0.1MG TABLET / ORAL-28 AB1 2015-05-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201088-001 AB1
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.
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 2026-08-01 22:54:32 2026-06 A201088-001 VIENVA 0.02MG;0.1MG TABLET / ORAL-28 AB1 2015-05-21 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A201088-001 AB1 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Vienva TM
Listing expiration 2026-12-31 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 63629-2344-1 Vienva TM 1 in 1 BLISTER PACK KIT 1 104 63629-2344-1 Vienva TM 3 in 1 CARTON KIT 3 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2344 VIENVA TM (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [BRYANT RANCH PREPACK] 104 Current NDC, Legacy NDC, 2 package rows 20241228_8b1b92f7-b736-436d-b06d-1fedeb970408.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63629-2344-1 63629234401 3 BLISTER PACK in 1 CARTON (63629-2344-1) / 1 KIT in 1 BLISTER PACK 3 blister pack 2021-04-26 0000-00-00 No No Current