SRONYX
- Product NDC
- 53002-1539
- 11-digit product format
- 530021539
- Labeler code
- 53002
- Product ID
- 53002-1539_44b1eeef-f515-4e1b-aaa2-9fb5486472eb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA077681
- Marketing category
- ANDA
- Marketing start
- 2016-08-03
- 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 |
|---|---|---|---|---|---|---|
| 53002-1539-1 | SRONYX | 1 in 1 BLISTER PACK | KIT | 1 | 5 | |
| 53002-1539-1 | SRONYX | 1 in 1 PACKAGE | KIT | 1 | 5 | |
| 53002-1539-3 | SRONYX | 1 in 1 BLISTER PACK | KIT | 1 | 5 | |
| 53002-1539-3 | SRONYX | 3 in 1 PACKAGE | KIT | 3 | 5 | |
| 53002-1539-6 | SRONYX | 6 in 1 PACKAGE | KIT | 6 | 5 | |
| 53002-1539-6 | SRONYX | 1 in 1 BLISTER PACK | KIT | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 53002-1539-6 | EA - Each | 53002-1539 | 9316aca5-dfa2-48de-9df6-4546a8cb992b | 1 | 2024-04-05 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-1539 | SRONYX (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 6 package rows | 20230609_1cfeddab-54d9-4d95-8997-7aac39383a80.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 753544 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Sronyx 28 Day] | BPCK | 1cfeddab-54d9-4d95-8997-7aac39383a80 | 5 |
| 748868 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 1cfeddab-54d9-4d95-8997-7aac39383a80 | 5 |
| 748868 | Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 1cfeddab-54d9-4d95-8997-7aac39383a80 | 5 |
| 748797 | inert 1 MG Oral Tablet | PSN | 1cfeddab-54d9-4d95-8997-7aac39383a80 | 5 |
| 242297 | levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 1cfeddab-54d9-4d95-8997-7aac39383a80 | 5 |
| 753544 | Sronyx 28 Day Pack | PSN | 1cfeddab-54d9-4d95-8997-7aac39383a80 | 5 |
| 242297 | ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet | SCD | 1cfeddab-54d9-4d95-8997-7aac39383a80 | 5 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 1cfeddab-54d9-4d95-8997-7aac39383a80 | 5 |
| 753544 | Sronyx 28 Day Pack | SY | 1cfeddab-54d9-4d95-8997-7aac39383a80 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53002-1539-1 | 53002153901 | 1 BLISTER PACK in 1 PACKAGE (53002-1539-1) > 1 KIT in 1 BLISTER PACK | 1 blister pack | 2018-10-22 | 0000-00-00 | No | No | Current |
| 53002-1539-3 | 53002153903 | 3 BLISTER PACK in 1 PACKAGE (53002-1539-3) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2018-10-22 | 0000-00-00 | No | No | Current |
| 53002-1539-6 | 53002153906 | 6 BLISTER PACK in 1 PACKAGE (53002-1539-6) > 1 KIT in 1 BLISTER PACK | 6 blister pack | 2018-10-22 | 0000-00-00 | No | No | Current |