Twirla
- Product NDC
- 71671-100
- 11-digit product format
- 716710100
- Labeler code
- 71671
- Product ID
- 71671-100_722214f4-2c40-93f5-32ea-a297d82b32d0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levonorgestrel/ethinyl estradiol
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Agile Therapeutics, Inc.
- Application
- NDA204017
- Marketing category
- NDA
- Marketing start
- 2020-09-11
- Substance
- ETHINYL ESTRADIOL; LEVONORGESTREL
- Active strength
- 2.3; 2.6 mg/1; mg/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Twirla
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | 2.3 mg/1 |
| LEVONORGESTREL | 2.6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 5W7SIA7YZW |
| Rxcui | 2396242, 2396253, 2396258, 2396259 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71671-100-01 | Twirla | 1 in 1 CARTON | PATCH | 1 | | 7 |
| 71671-100-03 | Twirla | 3 in 1 CARTON | PATCH | 3 | | 7 |
| 71671-100-11 | Twirla | 1 in 1 POUCH | PATCH | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71671-100 | TWIRLA (LEVONORGESTREL/ETHINYL ESTRADIOL) PATCH [AGILE THERAPEUTICS, INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20240712_bcaf8db0-1750-425d-b008-255b5e7a9cc6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71671-100-01 | 71671010001 | 1 POUCH in 1 CARTON (71671-100-01) / 1 PATCH in 1 POUCH (71671-100-11) | 1 pouch | 2020-09-11 | 0000-00-00 | No | No | Current |
| 71671-100-03 | 71671010003 | 3 POUCH in 1 CARTON (71671-100-03) / 1 PATCH in 1 POUCH (71671-100-11) | 3 pouch | 2020-09-11 | 0000-00-00 | No | No | Current |
| 71671-100-11 | 71671010011 | 1 in 1 POUCH | | | | | | Historical |