FDA.reportPublic FDA data

Gwyn Lo

Product NDC
49502-627
11-digit product format
495020627
Labeler code
49502
Product ID
49502-627_bbf180f5-37ea-4dc4-a653-2a2c96215c45
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
2026-10-01
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 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219990-001GWYN LOETHINYL ESTRADIOL; NORELGESTROMIN0.02MG/24HR;0.22MG/24HRSYSTEM / TRANSDERMALRLD, RS2026-07-28

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219990-001NP2029-07-28

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N219990-001GWYN LO0.02MG/24HR;0.22MG/24HRSYSTEM / TRANSDERMALRLD, RS2026-07-28c2088c7a36db…
2026-09-14 22:38:342026-08N219990-001GWYN LO0.02MG/24HR;0.22MG/24HRSYSTEM / TRANSDERMALRLD, RS2026-07-2884e616aacf4f…
2026-08-18 06:07:402026-07N219990-001GWYN LO0.02MG/24HR;0.22MG/24HRSYSTEM / TRANSDERMALRLD, RS2026-07-28caaa826d4ba7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-10-15 13:18:302026-09N219990-001NP2029-07-28c2088c7a36db…
2026-09-14 22:38:342026-08N219990-001NP2029-07-2884e616aacf4f…

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
IngredientStrength
NORELGESTROMIN220 ug/d
ETHINYL ESTRADIOL20 ug/d

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49502-627-62495020627623 POUCH in 1 CARTON (49502-627-62) / 1 PATCH in 1 POUCH (49502-627-61) / 7 d in 1 PATCH3 pouch2026-10-01NoNoCurrent