Etonogestrel and Ethinyl Estradiol
- Product NDC
- 0093-7679
- 11-digit product format
- 000937679
- Labeler code
- 0093
- Product ID
- 0093-7679_d0827dbf-9df5-4438-a0c2-92d7d593e71c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Etonogestrel and Ethinyl Estradiol
- Dosage form
- INSERT, EXTENDED RELEASE
- Route
- VAGINAL
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- ANDA204305
- Marketing category
- ANDA
- Marketing start
- 2021-01-19
- Marketing end
- 2027-07-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Etonogestrel and Ethinyl Estradiol
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 |
|---|
| 0093-7679-01 | Etonogestrel and Ethinyl Estradiol | 21 d in 1 POUCH | INSERT, EXTENDED RELEASE | 21 | | 5 |
| 0093-7679-02 | Etonogestrel and Ethinyl Estradiol | 3 in 1 CARTON | INSERT, EXTENDED RELEASE | 3 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0093-7679 | ETONOGESTREL AND ETHINYL ESTRADIOL INSERT, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221101_a8cc104a-d522-49ad-af54-2f312b829b61.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 |
|---|
| 0093-7679-01 | 00093767901 | 21 d in 1 POUCH | 21 d | | | | | Historical |
| 0093-7679-02 | 00093767902 | 3 POUCH in 1 CARTON (0093-7679-02) / 21 d in 1 POUCH (0093-7679-01) | 3 pouch | 2021-01-19 | 2027-07-31 | No | No | Current |