Aurovela 1.5/30
- Product NDC
- 65862-935
- 11-digit product format
- 658620935
- Labeler code
- 65862
- Product ID
- 65862-935_07926174-446c-43dc-9db1-db8b78432645
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate and Ethinyl Estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA207581
- Marketing category
- ANDA
- Marketing start
- 2017-06-26
- Substance
- ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- 30; 1.5 ug/1; mg/1
- 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
- Aurovela 1.5/30
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | 30 ug/1 |
| NORETHINDRONE ACETATE | 1.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 9S44LIC7OJ |
| Rxcui | 1359022, 1359028, 1928007 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-935-54 | Aurovela 1.5/30 | 1 in 1 POUCH | TABLET | 1 | | 12 |
| 65862-935-54 | Aurovela 1.5/30 | 5 in 1 CARTON | TABLET | 5 | | 12 |
| 65862-935-74 | Aurovela 1.5/30 | 1 in 1 POUCH | TABLET | 1 | | 12 |
| 65862-935-74 | Aurovela 1.5/30 | 3 in 1 CARTON | TABLET | 3 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-935 | AUROVELA 1.5/30 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL) TABLET [AUROBINDO PHARMA LIMITED] | 12 | Current NDC, Legacy NDC, 4 package rows | 20231123_b146e49c-a0fc-4f3d-9ad6-99e8257fa139.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 |
|---|
| 65862-935-54 | 65862093554 | 5 POUCH in 1 CARTON (65862-935-54) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK | 5 pouch | 2017-06-26 | 0000-00-00 | No | No | Current |
| 65862-935-74 | 65862093574 | 3 POUCH in 1 CARTON (65862-935-74) / 1 BLISTER PACK in 1 POUCH / 21 TABLET in 1 BLISTER PACK | 3 pouch | 2017-06-26 | 0000-00-00 | No | No | Current |