Twirla
These highlights do not include all the information needed to use TWIRLA safely and effectively. See full prescribing information for TWIRLA. TWIRLA (levonorgestrel and ethinyl estradiol) transdermal systemInitial U.S. Approval: 1968 (norgestrel and ethinyl estradiol)
Approved
Approval ID
bcaf8db0-1750-425d-b008-255b5e7a9cc6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2023
Manufacturers
FDA
Agile Therapeutics, Inc.
DUNS: 102678187
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levonorgestrel/ethinyl estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71671-100
Application NumberNDA204017
Product Classification
M
Marketing Category
C73594
G
Generic Name
levonorgestrel/ethinyl estradiol
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateSeptember 11, 2020
FDA Product Classification
INGREDIENTS (13)
LEVONORGESTRELActive
Quantity: 2.60 mg in 1 1
Code: 5W7SIA7YZW
Classification: ACTIB
ETHINYL ESTRADIOLActive
Quantity: 2.30 mg in 1 1
Code: 423D2T571U
Classification: ACTIB
ETHYL LACTATEInactive
Code: F3P750VW8I
Classification: IACT
DIMETHYL SULFOXIDEInactive
Code: YOW8V9698H
Classification: IACT
LAURYL LACTATEInactive
Code: G5SU0BFK7O
Classification: IACT
POLYISOBUTYLENE (55000 MW)Inactive
Code: TQ77WR8A02
Classification: IACT
CAPRIC ACIDInactive
Code: 4G9EDB6V73
Classification: IACT
POLYISOBUTYLENE (1100000 MW)Inactive
Code: FLT10CH37X
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
POLYBUTENE (1400 MW)Inactive
Code: 1NA5AO9GH7
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HEPTANEInactive
Code: 456148SDMJ
Classification: IACT
CROSPOVIDONE (12 MPA.S AT 5%)Inactive
Code: 40UAA97IT9
Classification: IACT