Home NDC 63629-2351 Tri-Lo- Estarylla
Product NDC 63629-2351
11-digit product format 636292351
Labeler code 63629
Product ID 63629-2351_026c9eb0-ce11-45a6-92ab-599bb52142bc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name norgestimate and ethinyl estradiol
Dosage form KIT
Labeler Bryant Ranch Prepack
Application ANDA091232
Marketing category ANDA
Marketing start 2018-01-01
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 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 A091232-001 TRI-LO-ESTARYLLA ETHINYL ESTRADIOL; NORGESTIMATE 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET / ORAL-28 AB 2015-06-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091232-001 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.
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 A091232-001 TRI-LO-ESTARYLLA 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG TABLET / ORAL-28 AB 2015-06-29 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 A091232-001 AB 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 Tri-Lo- Estarylla
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 578732 Internal RxNorm lookup 748797 Internal RxNorm lookup 749155 Internal RxNorm lookup 749156 Internal RxNorm lookup 749157 Internal RxNorm lookup 1722676 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 63629-2351-1 Tri-Lo- Estarylla 1 in 1 BLISTER PACK KIT 1 104 63629-2351-1 Tri-Lo- Estarylla 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 63629-2351 TRI-LO- ESTARYLLA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [BRYANT RANCH PREPACK] 104 Current NDC, Legacy NDC, 2 package rows 20240523_90f7ab24-7839-4408-9a74-07bb6a79eacc.zip
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 63629-2351-1 63629235101 3 BLISTER PACK in 1 CARTON (63629-2351-1) / 1 KIT in 1 BLISTER PACK 3 blister pack 2023-02-10 0000-00-00 No No Current