Home NDC 49502-627 Gwyn Lo
Product NDC 49502-627
11-digit product format 495020627
Labeler code 49502
Product ID 49502-627_e92741f4-87fe-429f-b5b5-c558ed5f4fa9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name norelgestromin and ethinyl estradiol
Dosage form PATCH
Route TRANSDERMAL
Labeler Viatris Specialty LLC
Application NDA219990
Marketing category NDA
Marketing start 2026-07-28
Substance NORELGESTROMIN; ETHINYL ESTRADIOL
Active strength 220; 20 ug/d; ug/d
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
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 43 .
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 N219990-001 GWYN LO ETHINYL ESTRADIOL; NORELGESTROMIN 0.02MG/24HR;0.22MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2026-07-28
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219990-001 NP 2029-07-28
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 2026-09-14 22:38:34 2026-08 N219990-001 GWYN LO 0.02MG/24HR;0.22MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2026-07-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219990-001 GWYN LO 0.02MG/24HR;0.22MG/24HR SYSTEM / TRANSDERMAL RLD, RS 2026-07-28 caaa826d4ba7…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 N219990-001 NP 2029-07-28 84e616aacf4f…
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 Gwyn Lo
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NORELGESTROMIN 220 ug/d ETHINYL ESTRADIOL 20 ug/d
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R0TAY3X631 Internal UNII lookup 423D2T571U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2749430 Internal RxNorm lookup 2749437 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 Gwyn Lo NORELGESTROMIN AND ETHINYL ESTRADIOL Viatris Specialty LLC e92741f4-87fe-429f-b5b5-c558ed5f4fa9 2026-07-06 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 219990 application number: NDA219990 ndc (product): 49502-627