Azurette
- Product NDC
- 53002-1600
- 11-digit product format
- 530021600
- Labeler code
- 53002
- Product ID
- 53002-1600_f38a7e25-6b84-49c8-892b-633835d57e4a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA075863
- Marketing category
- ANDA
- Marketing start
- 2016-11-14
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-1600-1 | Azurette | 1 in 1 PACKAGE | KIT | 1 | 4 | |
| 53002-1600-1 | Azurette | 1 in 1 BLISTER PACK | KIT | 1 | 4 | |
| 53002-1600-3 | Azurette | 1 in 1 BLISTER PACK | KIT | 1 | 4 | |
| 53002-1600-3 | Azurette | 3 in 1 PACKAGE | KIT | 3 | 4 | |
| 53002-1600-6 | Azurette | 6 in 1 PACKAGE | KIT | 6 | 4 | |
| 53002-1600-6 | Azurette | 1 in 1 BLISTER PACK | KIT | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-1600 | AZURETTE (DESOGESTREL/ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [RPK PHARMACEUTICALS, INC.] | 4 | Legacy NDC, 6 package rows | 20201217_389c0c8b-b34d-47be-a45d-7ce2d6050382.zip |
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 | 389c0c8b-b34d-47be-a45d-7ce2d6050382 | 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 | 389c0c8b-b34d-47be-a45d-7ce2d6050382 | 4 |
| 831872 | Azurette 28 Day Pack | PSN | 389c0c8b-b34d-47be-a45d-7ce2d6050382 | 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 | 389c0c8b-b34d-47be-a45d-7ce2d6050382 | 4 |
| 249357 | desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 389c0c8b-b34d-47be-a45d-7ce2d6050382 | 4 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | PSN | 389c0c8b-b34d-47be-a45d-7ce2d6050382 | 4 |
| 748797 | inert 1 MG Oral Tablet | PSN | 389c0c8b-b34d-47be-a45d-7ce2d6050382 | 4 |
| 249357 | desogestrel 0.15 MG / ethinyl estradiol 0.02 MG Oral Tablet | SCD | 389c0c8b-b34d-47be-a45d-7ce2d6050382 | 4 |
| 248310 | ethinyl estradiol 0.01 MG Oral Tablet | SCD | 389c0c8b-b34d-47be-a45d-7ce2d6050382 | 4 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 389c0c8b-b34d-47be-a45d-7ce2d6050382 | 4 |
| 831872 | Azurette 28 Day Pack | SY | 389c0c8b-b34d-47be-a45d-7ce2d6050382 | 4 |
| 248310 | ethinyl estradiol 10 MCG Oral Tablet | SY | 389c0c8b-b34d-47be-a45d-7ce2d6050382 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-1600-1 | 53002160001 | 1 BLISTER PACK in 1 PACKAGE (53002-1600-1) > 1 KIT in 1 BLISTER PACK | 1 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1600-3 | 53002160003 | 3 BLISTER PACK in 1 PACKAGE (53002-1600-3) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1600-6 | 53002160006 | 6 BLISTER PACK in 1 PACKAGE (53002-1600-6) > 1 KIT in 1 BLISTER PACK | 6 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |