ALTAVERA
- Product NDC
- 70700-116
- 11-digit product format
- 707000116
- Labeler code
- 70700
- Product ID
- 70700-116_cd0fbf86-78dd-a8f2-7399-112a042ab767
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Xiromed, LLC.
- Application
- ANDA079102
- Marketing category
- ANDA
- Marketing start
- 2022-09-01
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ALTAVERA
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 238019, 748797, 748878, 1006065 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70700-116-85 | ALTAVERA | 3 in 1 CARTON | KIT | 3 | 12 | |
| 70700-116-85 | ALTAVERA | 1 in 1 BLISTER PACK | KIT | 1 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70700-116-84 | EA - Each | 70700-116 | bf63448a-6326-4b28-8760-10cf1b0698fd | 1 | 2018-07-03 |
| 70700-116-85 | EA - Each | 70700-116 | f7260c70-4009-4be5-bda7-0416767dba7f | 1 | 2018-07-03 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1006065 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Altavera 28 Day] | BPCK | c607816d-0da9-4960-9723-69f28aa3f2f2 | 103 |
| 748878 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | c607816d-0da9-4960-9723-69f28aa3f2f2 | 103 |
| 1006065 | Altavera 28 Day Pack | PSN | c607816d-0da9-4960-9723-69f28aa3f2f2 | 103 |
| 748878 | Eth estra-Levnorgest 0.03-0.15 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | c607816d-0da9-4960-9723-69f28aa3f2f2 | 103 |
| 748797 | inert 1 MG Oral Tablet | PSN | c607816d-0da9-4960-9723-69f28aa3f2f2 | 103 |
| 238019 | levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | c607816d-0da9-4960-9723-69f28aa3f2f2 | 103 |
| 238019 | ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet | SCD | c607816d-0da9-4960-9723-69f28aa3f2f2 | 103 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | c607816d-0da9-4960-9723-69f28aa3f2f2 | 103 |
| 1006065 | Altavera 28 Day Regimen | SY | c607816d-0da9-4960-9723-69f28aa3f2f2 | 103 |
| 1006065 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Altavera 28 Day] | BPCK | 4701e72b-6378-a771-fb88-1b703031a8bc | 12 |
| 748878 | {21 (ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 4701e72b-6378-a771-fb88-1b703031a8bc | 12 |
| 1006065 | Altavera 28 Day Pack | PSN | 4701e72b-6378-a771-fb88-1b703031a8bc | 12 |
| 748878 | Eth estra-Levnorgest 0.03-0.15 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 4701e72b-6378-a771-fb88-1b703031a8bc | 12 |
| 748797 | inert 1 MG Oral Tablet | PSN | 4701e72b-6378-a771-fb88-1b703031a8bc | 12 |
| 238019 | levonorgestrel 0.15 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | 4701e72b-6378-a771-fb88-1b703031a8bc | 12 |
| 238019 | ethinyl estradiol 0.03 MG / levonorgestrel 0.15 MG Oral Tablet | SCD | 4701e72b-6378-a771-fb88-1b703031a8bc | 12 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 4701e72b-6378-a771-fb88-1b703031a8bc | 12 |
| 1006065 | Altavera 28 Day Regimen | SY | 4701e72b-6378-a771-fb88-1b703031a8bc | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70700-116-85 | 70700011685 | 3 BLISTER PACK in 1 CARTON (70700-116-85) / 1 KIT in 1 BLISTER PACK | 3 blister pack | 2023-03-02 | 0000-00-00 | No | No | Current |