FDA.reportPublic FDA data

Gwyn Lo

Product NDC
49502-627
Requested package NDC
49502-627-62
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 43.

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
2026-09-14 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
2026-09-14 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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gwyn LoNORELGESTROMIN AND ETHINYL ESTRADIOLViatris Specialty LLCe92741f4-87fe-429f-b5b5-c558ed5f4fa92026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 219990
application number: NDA219990
ndc (package): 49502-627-62
ndc (product): 49502-627
ndc11 (package): 49502062762

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