AVERI
- Product NDC
- 75854-604
- 11-digit product format
- 758540604
- Labeler code
- 75854
- Product ID
- 75854-604_3bc4c615-77f6-47b5-af57-ebefeed6cca9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- desogestrel and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Avion Pharmaceuticals, LLC
- Application
- ANDA218933
- Marketing category
- ANDA
- Marketing start
- 2025-06-05
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AVERI
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 240707, 2672922, 2716396, 2716397 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75854-604-01 | AVERI | 1 in 1 CARTON | KIT | 1 | 2 | |
| 75854-604-01 | AVERI | 1 in 1 BLISTER PACK | KIT | 1 | 2 | |
| 75854-604-03 | AVERI | 3 in 1 CARTON | KIT | 3 | 2 | |
| 75854-604-03 | AVERI | 1 in 1 BLISTER PACK | KIT | 1 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75854-604-01 | EA - Each | 75854-604 | 6bd7832d-fa83-473b-9c75-7c2f3bba47d3 | 1 | 2025-07-08 |
| 75854-604-03 | EA - Each | 75854-604 | e701e647-facd-434e-b88d-540e6db9918b | 1 | 2025-07-08 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2716397 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [Averi 28 Day] | BPCK | 91359e20-0de1-4995-b525-58b7544e34dc | 2 |
| 2716396 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack | GPCK | 91359e20-0de1-4995-b525-58b7544e34dc | 2 |
| 2716397 | Averi 28 Day Pack | PSN | 91359e20-0de1-4995-b525-58b7544e34dc | 2 |
| 2716396 | desogest-eth estra 0.15-0.03 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day Pack | PSN | 91359e20-0de1-4995-b525-58b7544e34dc | 2 |
| 240707 | desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | 91359e20-0de1-4995-b525-58b7544e34dc | 2 |
| 2672922 | ferrous bisglycinate 36.5 MG Oral Tablet | PSN | 91359e20-0de1-4995-b525-58b7544e34dc | 2 |
| 240707 | desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet | SCD | 91359e20-0de1-4995-b525-58b7544e34dc | 2 |
| 2672922 | ferrous bisglycinate 36.5 MG Oral Tablet | SCD | 91359e20-0de1-4995-b525-58b7544e34dc | 2 |
| 2716396 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } 28 Day Pack | SY | 91359e20-0de1-4995-b525-58b7544e34dc | 2 |
| 2716397 | Averi 28 Day Pack | SY | 91359e20-0de1-4995-b525-58b7544e34dc | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 75854-604-01 | 75854060401 | 1 BLISTER PACK in 1 CARTON (75854-604-01) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2025-06-05 | No | No | Historical |
| 75854-604-03 | 75854060403 | 3 BLISTER PACK in 1 CARTON (75854-604-03) / 1 KIT in 1 BLISTER PACK | 3 blister pack | 2025-06-05 | No | No | Historical |