ANNOVERA
- Product NDC
- 50261-313
- 11-digit product format
- 502610313
- Labeler code
- 50261
- Product ID
- 50261-313_17feae6d-baa1-4f2c-8989-c5400c2a1a88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- segesterone acetate and ethinyl estradiol
- Dosage form
- RING
- Route
- VAGINAL
- Labeler
- TherapeuticsMD, Inc.
- Application
- NDA209627
- Marketing category
- NDA
- Marketing start
- 2019-08-12
- Marketing end
- 0000-00-00
- Substance
- ETHINYL ESTRADIOL; SEGESTERONE ACETATE
- Active strength
- 17 mg/1; mg/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50261-313 | ANNOVERA (SEGESTERONE ACETATE AND ETHINYL ESTRADIOL) RING [THERAPEUTICSMD, INC.] | 6 | Legacy NDC | 20220824_37bb9ebd-2e99-4453-bbe6-9dd4a2897193.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50261-313-01 | 50261031301 | 1 POUCH in 1 CARTON (50261-313-01) > 1 RING in 1 POUCH | 1 pouch | 2019-08-12 | 0000-00-00 | No | No | Current |