Azurette
- Product NDC
- 51862-890
- 11-digit product format
- 518620890
- Labeler code
- 51862
- Product ID
- 51862-890_0f94b0b9-a7da-4030-9acf-542d6607d7fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- desogestrel/ethinyl estradiol and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA091247
- Marketing category
- ANDA
- Marketing start
- 2020-10-03
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azurette
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 248310, 249357, 748797, 759743, 831872 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51862-890-01 | Azurette | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 51862-890-01 | Azurette | 1 in 1 PACKET | KIT | 1 | 3 | |
| 51862-890-02 | Azurette | 1 in 1 CARTON | KIT | 1 | 3 | |
| 51862-890-02 | Azurette | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 51862-890-03 | Azurette | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 51862-890-03 | Azurette | 3 in 1 CARTON | KIT | 3 | 3 | |
| 51862-890-06 | Azurette | 1 in 1 BLISTER PACK | KIT | 1 | 3 | |
| 51862-890-06 | Azurette | 6 in 1 CARTON | KIT | 6 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51862-890-01 | EA - Each | 51862-890 | 0dd190f8-ff7f-4587-8c1f-8ea3300a4c53 | 1 | 2021-02-05 |
| 51862-890-06 | EA - Each | 51862-890 | 2d2aee71-3e47-4749-a04d-91a929718864 | 1 | 2021-02-05 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 831872 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack [Azurette 28 Day] | BPCK | 38e4e22d-ff3a-4c1a-9e07-b9f200014983 | 4 |
| 759743 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 38e4e22d-ff3a-4c1a-9e07-b9f200014983 | 4 |
| 831872 | Azurette 28 Day Pack | PSN | 38e4e22d-ff3a-4c1a-9e07-b9f200014983 | 4 |
| 759743 | Desogest-Eth estra 0.15-0.02 MG (21) Oral Tablet / Eth estra 0.01 MG (5) Oral Tablet / Inert 1 MG (2) Oral Tablet 28 Day Pack | PSN | 38e4e22d-ff3a-4c1a-9e07-b9f200014983 | 4 |
| 249357 | desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 38e4e22d-ff3a-4c1a-9e07-b9f200014983 | 4 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | PSN | 38e4e22d-ff3a-4c1a-9e07-b9f200014983 | 4 |
| 748797 | inert 1 MG Oral Tablet | PSN | 38e4e22d-ff3a-4c1a-9e07-b9f200014983 | 4 |
| 249357 | desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet | SCD | 38e4e22d-ff3a-4c1a-9e07-b9f200014983 | 4 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | SCD | 38e4e22d-ff3a-4c1a-9e07-b9f200014983 | 4 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 38e4e22d-ff3a-4c1a-9e07-b9f200014983 | 4 |
| 831872 | Azurette 28 Day Pack | SY | 38e4e22d-ff3a-4c1a-9e07-b9f200014983 | 4 |
| 248310 | ethinyl estradiol 10 MCG Oral Tablet | SY | 38e4e22d-ff3a-4c1a-9e07-b9f200014983 | 4 |
| 831872 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack [Azurette 28 Day] | BPCK | bff09a7b-aea6-460b-a263-44576e00f510 | 3 |
| 759743 | {21 (desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet) / 5 (ethinyl estradiol 0.01 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | bff09a7b-aea6-460b-a263-44576e00f510 | 3 |
| 831872 | Azurette 28 Day Pack | PSN | bff09a7b-aea6-460b-a263-44576e00f510 | 3 |
| 759743 | Desogest-Eth estra 0.15-0.02 MG (21) Oral Tablet / Eth estra 0.01 MG (5) Oral Tablet / Inert 1 MG (2) Oral Tablet 28 Day Pack | PSN | bff09a7b-aea6-460b-a263-44576e00f510 | 3 |
| 249357 | desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | bff09a7b-aea6-460b-a263-44576e00f510 | 3 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | PSN | bff09a7b-aea6-460b-a263-44576e00f510 | 3 |
| 748797 | inert 1 MG Oral Tablet | PSN | bff09a7b-aea6-460b-a263-44576e00f510 | 3 |
| 249357 | desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet | SCD | bff09a7b-aea6-460b-a263-44576e00f510 | 3 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | SCD | bff09a7b-aea6-460b-a263-44576e00f510 | 3 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | bff09a7b-aea6-460b-a263-44576e00f510 | 3 |
| 831872 | Azurette 28 Day Pack | SY | bff09a7b-aea6-460b-a263-44576e00f510 | 3 |
| 248310 | ethinyl estradiol 10 MCG Oral Tablet | SY | bff09a7b-aea6-460b-a263-44576e00f510 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51862-890-01 | 51862089001 | 1 BLISTER PACK in 1 PACKET (51862-890-01) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2020-10-03 | 0000-00-00 | No | No | Current |
| 51862-890-02 | 51862089002 | 1 BLISTER PACK in 1 CARTON (51862-890-02) / 1 KIT in 1 BLISTER PACK | 1 blister pack | 2020-10-03 | 0000-00-00 | No | No | Current |
| 51862-890-03 | 51862089003 | 3 BLISTER PACK in 1 CARTON (51862-890-03) / 1 KIT in 1 BLISTER PACK | 3 blister pack | 2020-10-03 | 0000-00-00 | No | No | Current |
| 51862-890-06 | 51862089006 | 6 BLISTER PACK in 1 CARTON (51862-890-06) > 1 KIT in 1 BLISTER PACK | 6 blister pack | 2020-10-03 | 0000-00-00 | No | No | Current |