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NDC 71671-0100-01 Twirla 2.3; 2.6 mg/1; mg/1 Details
Twirla 2.3; 2.6 mg/1; mg/1
Twirla is a TRANSDERMAL PATCH in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Agile Therapeutics, Inc.. The primary component is ETHINYL ESTRADIOL; LEVONORGESTREL.
Product Information
| NDC | 71671-0100 |
|---|---|
| Product ID | 71671-100_f70170ed-1a88-45e8-9ca4-50f203ac8420 |
| Associated GPIs | 25960002408820 |
| GCN Sequence Number | 080745 |
| GCN Sequence Number Description | levonorgestrel/ethin.estradiol PATCH TDWK 120-30/24H TRANSDERM |
| HIC3 | G8F |
| HIC3 Description | CONTRACEPTIVES,TRANSDERMAL |
| GCN | 47708 |
| HICL Sequence Number | 001460 |
| HICL Sequence Number Description | LEVONORGESTREL/ETHINYL ESTRADIOL |
| Brand/Generic | Brand |
| Proprietary Name | Twirla |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | levonorgestrel/ethinyl estradiol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | PATCH |
| Route | TRANSDERMAL |
| Active Ingredient Strength | 2.3; 2.6 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ETHINYL ESTRADIOL; LEVONORGESTREL |
| Labeler Name | Agile Therapeutics, Inc. |
| Pharmaceutical Class | Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA204017 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 71671-0100-01 (71671010001)
| NDC Package Code | 71671-100-01 |
|---|---|
| Billing NDC | 71671010001 |
| Package | 1 POUCH in 1 CARTON (71671-100-01) / 1 PATCH in 1 POUCH (71671-100-11) |
| Marketing Start Date | 2020-09-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |