Etonogestrel and Ethinyl Estradiol Vaginal
- Product NDC
- 42291-478
- 11-digit product format
- 422910478
- Labeler code
- 42291
- Product ID
- 42291-478_1cbd9870-3ef2-b5c9-e063-6394a90a2dbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etonogestrel and Ethinyl Estradiol Vaginal
- Dosage form
- RING
- Route
- VAGINAL
- Labeler
- AvKARE
- Application
- ANDA211157
- Marketing category
- ANDA
- Marketing start
- 2023-09-21
- Substance
- ETHINYL ESTRADIOL; ETONOGESTREL
- Active strength
- .015; .12 mg/d; mg/d
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Etonogestrel and Ethinyl Estradiol Vaginal
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | .015 mg/d |
| ETONOGESTREL | .12 mg/d |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 304GTH6RNH |
| Rxcui | 1367436 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-478-03 | Etonogestrel and Ethinyl Estradiol Vaginal | 3 in 1 CARTON | RING | 3 | | 4 |
| 42291-478-11 | Etonogestrel and Ethinyl Estradiol Vaginal | 21 d in 1 POUCH | RING | 21 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-478 | ETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RING [AVKARE] | 4 | Current NDC, 2 package rows | 20240710_05e172aa-e18a-427b-e063-6294a90ae22f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-478-03 | 42291047803 | 3 POUCH in 1 CARTON (42291-478-03) / 21 d in 1 POUCH (42291-478-11) | 3 pouch | 2023-09-21 | No | No | Current |
| 42291-478-11 | 42291047811 | 21 d in 1 POUCH | 21 d | | | | Historical |