Balcoltra
- Product NDC
- 75854-602
- 11-digit product format
- 758540602
- Labeler code
- 75854
- Product ID
- 75854-602_57bb625e-d567-432d-a6c2-44b329de9b7b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levonorgestrel and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Avion Pharmaceuticals
- Application
- NDA208612
- Marketing category
- NDA
- Marketing start
- 2018-04-10
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Balcoltra
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 242297, 1999026, 2672922, 2672923 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75854-602-02 | Balcoltra | 1 in 1 BLISTER PACK | KIT | 1 | 6 | |
| 75854-602-02 | Balcoltra | 2 in 1 CARTON | KIT | 2 | 6 | |
| 75854-602-03 | Balcoltra | 1 in 1 BLISTER PACK | KIT | 1 | 6 | |
| 75854-602-03 | Balcoltra | 3 in 1 CARTON | KIT | 3 | 6 | |
| 75854-602-28 | Balcoltra | 1 in 1 BLISTER PACK | KIT | 1 | 6 | |
| 75854-602-28 | Balcoltra | 1 in 1 CARTON | KIT | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 75854-602-02 | EA - Each | 75854-602 | 18d9116e-db2f-403a-8160-abb897d3f42e | 1 | 2019-01-24 |
| 75854-602-03 | EA - Each | 75854-602 | 4fe681a6-d009-47a1-8700-565cedea2722 | 1 | 2018-05-09 |
| 75854-602-28 | EA - Each | 75854-602 | 38a2e389-f2a2-43e9-8124-9baae43d4727 | 1 | 2018-05-09 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1999026 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack [Balcoltra 28 Day] | BPCK | 752ab698-4b48-4614-8016-d1d33ee7c007 | 6 |
| 2672923 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (ferrous bisglycinate 36.5 MG Oral Tablet) } Pack | GPCK | 752ab698-4b48-4614-8016-d1d33ee7c007 | 6 |
| 1999026 | Balcoltra 28 Day Pack | PSN | 752ab698-4b48-4614-8016-d1d33ee7c007 | 6 |
| 2672923 | Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / ferrous bisglycinate 36.5 MG (7) Oral Tablet 28 Day Pack | PSN | 752ab698-4b48-4614-8016-d1d33ee7c007 | 6 |
| 2672922 | ferrous bisglycinate 36.5 MG Oral Tablet | PSN | 752ab698-4b48-4614-8016-d1d33ee7c007 | 6 |
| 242297 | levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 752ab698-4b48-4614-8016-d1d33ee7c007 | 6 |
| 242297 | ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet | SCD | 752ab698-4b48-4614-8016-d1d33ee7c007 | 6 |
| 2672922 | ferrous bisglycinate 36.5 MG Oral Tablet | SCD | 752ab698-4b48-4614-8016-d1d33ee7c007 | 6 |
| 1999026 | Balcoltra 28 Day Pack | SY | 752ab698-4b48-4614-8016-d1d33ee7c007 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 75854-602-02 | 75854060202 | 2 BLISTER PACK in 1 CARTON (75854-602-02) / 1 KIT in 1 BLISTER PACK | 2 blister pack | 2018-04-10 | 0000-00-00 | No | No | Current |
| 75854-602-03 | 75854060203 | 3 BLISTER PACK in 1 CARTON (75854-602-03) / 1 KIT in 1 BLISTER PACK | 3 blister pack | 2018-04-10 | 0000-00-00 | No | No | Current |
| 75854-602-28 | 75854060228 | 1 BLISTER PACK in 1 CARTON (75854-602-28) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2018-04-10 | 0000-00-00 | No | No | Current |