Aurovela Fe 1/20
- Product NDC
- 65862-940
- 11-digit product format
- 658620940
- Labeler code
- 65862
- Product ID
- 65862-940_2fb192cb-1d17-41ce-8fbb-04f188f6079b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
- Dosage form
- KIT
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA207505
- Marketing category
- ANDA
- Marketing start
- 2017-06-16
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Aurovela Fe 1/20
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 259176, 1358762, 1358763, 1926946 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-940-58 | Aurovela Fe 1/20 | 5 in 1 CARTON | KIT | 5 | 12 | |
| 65862-940-58 | Aurovela Fe 1/20 | 1 in 1 POUCH | KIT | 1 | 12 | |
| 65862-940-87 | Aurovela Fe 1/20 | 1 in 1 BLISTER PACK | KIT | 1 | 12 | |
| 65862-940-87 | Aurovela Fe 1/20 | 1 in 1 POUCH | KIT | 1 | 12 | |
| 65862-940-88 | Aurovela Fe 1/20 | 3 in 1 CARTON | KIT | 3 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-940-87 | EA - Each | 65862-940 | 7782737d-806d-4f06-9634-1174e75636ae | 1 | 2019-05-02 |
| 65862-940-88 | EA - Each | 65862-940 | 7beda55d-94ab-45ba-bcf2-a54155ba1ac9 | 1 | 2019-05-02 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 65862-940 | AUROVELA FE 1/20 (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [AUROBINDO PHARMA LIMITED] | 12 | Current NDC, Legacy NDC, 5 package rows | 20231123_83513d13-5352-4d86-9dfd-fd1e456087c0.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1926946 | {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack [Aurovela Fe 1/20 28 Day] | BPCK | 83513d13-5352-4d86-9dfd-fd1e456087c0 | 12 |
| 1358763 | {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack | GPCK | 83513d13-5352-4d86-9dfd-fd1e456087c0 | 12 |
| 1926946 | Aurovela Fe 1/20 28 Day Pack | PSN | 83513d13-5352-4d86-9dfd-fd1e456087c0 | 12 |
| 1358763 | Eth-estra-Noreth Ac 0.02-1 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack | PSN | 83513d13-5352-4d86-9dfd-fd1e456087c0 | 12 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | PSN | 83513d13-5352-4d86-9dfd-fd1e456087c0 | 12 |
| 1358762 | norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 83513d13-5352-4d86-9dfd-fd1e456087c0 | 12 |
| 1358762 | ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet | SCD | 83513d13-5352-4d86-9dfd-fd1e456087c0 | 12 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | SCD | 83513d13-5352-4d86-9dfd-fd1e456087c0 | 12 |
| 1926946 | Aurovela Fe 1/20 28 Day Pack | SY | 83513d13-5352-4d86-9dfd-fd1e456087c0 | 12 |
| 1358762 | ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Tablet | SY | 83513d13-5352-4d86-9dfd-fd1e456087c0 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-940-58 | 65862094058 | 5 POUCH in 1 CARTON (65862-940-58) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | 5 pouch | 2017-06-16 | 0000-00-00 | No | No | Current |
| 65862-940-87 | 65862094087 | 1 in 1 BLISTER PACK | Historical | |||||
| 65862-940-88 | 65862094088 | 3 POUCH in 1 CARTON (65862-940-88) / 1 BLISTER PACK in 1 POUCH (65862-940-87) / 1 KIT in 1 BLISTER PACK | 3 pouch | 2017-06-16 | 0000-00-00 | No | No | Current |