Afirmelle
- Product NDC
- 65862-849
- 11-digit product format
- 658620849
- Labeler code
- 65862
- Product ID
- 65862-849_47af327f-2969-4cbf-9aa8-39c8003df043
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA206886
- Marketing category
- ANDA
- Marketing start
- 2016-11-14
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Afirmelle
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 242297, 748797, 748868, 1860414 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-849 | AFIRMELLE (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED] | 9 | Current NDC, Legacy NDC, 5 package rows | 20240927_dd6122cd-b7ba-4fe3-bde5-910882475b67.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 |
|---|
| 65862-849-28 | 65862084928 | 1 in 1 POUCH | | | | | | Historical |
| 65862-849-88 | 65862084988 | 3 POUCH in 1 CARTON (65862-849-88) / 1 BLISTER PACK in 1 POUCH (65862-849-28) / 1 KIT in 1 BLISTER PACK | 3 pouch | 2016-11-14 | 0000-00-00 | No | No | Current |
| 65862-849-92 | 65862084992 | 6 POUCH in 1 CARTON (65862-849-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK | 6 pouch | 2016-11-14 | 0000-00-00 | No | No | Current |