SRONYX
- Product NDC
- 51862-545
- 11-digit product format
- 518620545
- Labeler code
- 51862
- Product ID
- 51862-545_3aadfd82-3d97-6e99-e063-6294a90a958e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levonorgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA077681
- Marketing category
- ANDA
- Marketing start
- 2016-08-03
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SRONYX
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 242297, 748797, 748868, 753544 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51862-545-01 | SRONYX | 1 in 1 BLISTER PACK | KIT | 1 | 8 | |
| 51862-545-06 | SRONYX | 6 in 1 CARTON | KIT | 6 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51862-545-01 | EA - Each | 51862-545 | 0fe45b1e-3c77-41b7-97bd-e67643e24ebd | 1 | 2018-01-12 |
| 51862-545-06 | EA - Each | 51862-545 | 3f5f4cd5-4dc7-48a5-b89d-eb822a6e56c7 | 1 | 2016-09-02 |
DailyMed Dashboard NDC Coverage#
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 | b0c1a495-4cd7-4664-8fe4-714812f53c71 | 8 |
| 748868 | {21 (ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | b0c1a495-4cd7-4664-8fe4-714812f53c71 | 8 |
| 748868 | Eth estra-Levonorgest 0.02-0.1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | b0c1a495-4cd7-4664-8fe4-714812f53c71 | 8 |
| 748797 | inert 1 MG Oral Tablet | PSN | b0c1a495-4cd7-4664-8fe4-714812f53c71 | 8 |
| 242297 | levonorgestrel 0.1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | b0c1a495-4cd7-4664-8fe4-714812f53c71 | 8 |
| 753544 | Sronyx 28 Day Pack | PSN | b0c1a495-4cd7-4664-8fe4-714812f53c71 | 8 |
| 242297 | ethinyl estradiol 0.02 MG / levonorgestrel 0.1 MG Oral Tablet | SCD | b0c1a495-4cd7-4664-8fe4-714812f53c71 | 8 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | b0c1a495-4cd7-4664-8fe4-714812f53c71 | 8 |
| 753544 | Sronyx 28 Day Pack | SY | b0c1a495-4cd7-4664-8fe4-714812f53c71 | 8 |
| 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 |
|---|---|---|---|---|---|---|---|---|
| 51862-545-01 | 51862054501 | 1 in 1 BLISTER PACK | Historical | |||||
| 51862-545-06 | 51862054506 | 6 BLISTER PACK in 1 CARTON (51862-545-06) > 1 KIT in 1 BLISTER PACK (51862-545-01) | 6 blister pack | 2016-08-03 | 0000-00-00 | No | No | Current |