Low-Ogestrel
- Product NDC
- 51862-564
- 11-digit product format
- 518620564
- Labeler code
- 51862
- Product ID
- 51862-564_051f62cc-9a4a-40bc-9a9b-e7942354c0dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- Mayne Pharma Inc.
- Application
- ANDA075288
- Marketing category
- ANDA
- Marketing start
- 2016-08-03
- Marketing end
- 2027-01-31
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Low-Ogestrel
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 311359, 748797, 749786, 750244 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 51862-564-06 | 2025-07-29 | C162847 | 48780-1 | 2cef2736-a89f-d83d-e063-dadaa90ab31f | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 51862-564-06 | 2025-07-29 | C162847 | 48780-1 | 2cef2736-a89f-d83d-e063-dadaa90ab31f | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 51862-564-06 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a89f-d83d-e063-dadaa90ab31f | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 51862-564-06 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-a89f-d83d-e063-dadaa90ab31f | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51862-564-01 | Low-Ogestrel | 1 in 1 BLISTER PACK | KIT | 1 | 14 | |
| 51862-564-06 | Low-Ogestrel | 6 in 1 CARTON | KIT | 6 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51862-564-01 | EA - Each | 51862-564 | 82c46f68-316a-4410-afe0-a22be0817acd | 1 | 2016-10-06 |
| 51862-564-06 | EA - Each | 51862-564 | 4285224e-1182-4803-b4a9-215ca85d763a | 1 | 2016-09-02 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 750244 | {21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Low-Ogestrel 28 Day] | BPCK | 8755b020-d439-4ba2-a60b-6c57a15ece55 | 14 |
| 749786 | {21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | 8755b020-d439-4ba2-a60b-6c57a15ece55 | 14 |
| 749786 | eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | 8755b020-d439-4ba2-a60b-6c57a15ece55 | 14 |
| 748797 | inert 1 MG Oral Tablet | PSN | 8755b020-d439-4ba2-a60b-6c57a15ece55 | 14 |
| 750244 | Low-Ogestrel 28 Day Pack | PSN | 8755b020-d439-4ba2-a60b-6c57a15ece55 | 14 |
| 311359 | norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | 8755b020-d439-4ba2-a60b-6c57a15ece55 | 14 |
| 311359 | ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet | SCD | 8755b020-d439-4ba2-a60b-6c57a15ece55 | 14 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | 8755b020-d439-4ba2-a60b-6c57a15ece55 | 14 |
| 311359 | ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral Tablet | SY | 8755b020-d439-4ba2-a60b-6c57a15ece55 | 14 |
| 750244 | Low-Ogestrel 28 Day Pack | SY | 8755b020-d439-4ba2-a60b-6c57a15ece55 | 14 |
| 750244 | {21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Low-Ogestrel 28 Day] | BPCK | d2bfe067-3948-4f1e-bfea-f16e1b3fd430 | 4 |
| 749786 | {21 (ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | d2bfe067-3948-4f1e-bfea-f16e1b3fd430 | 4 |
| 749786 | eth estra-norgestrel 0.03-0.3 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | d2bfe067-3948-4f1e-bfea-f16e1b3fd430 | 4 |
| 748797 | inert 1 MG Oral Tablet | PSN | d2bfe067-3948-4f1e-bfea-f16e1b3fd430 | 4 |
| 750244 | Low-Ogestrel 28 Day Pack | PSN | d2bfe067-3948-4f1e-bfea-f16e1b3fd430 | 4 |
| 311359 | norgestrel 0.3 MG / ethinyl estradiol 0.03 MG Oral Tablet | PSN | d2bfe067-3948-4f1e-bfea-f16e1b3fd430 | 4 |
| 311359 | ethinyl estradiol 0.03 MG / norgestrel 0.3 MG Oral Tablet | SCD | d2bfe067-3948-4f1e-bfea-f16e1b3fd430 | 4 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | d2bfe067-3948-4f1e-bfea-f16e1b3fd430 | 4 |
| 311359 | ethinyl estradiol 30 MCG / norgestrel 0.3 MG Oral Tablet | SY | d2bfe067-3948-4f1e-bfea-f16e1b3fd430 | 4 |
| 750244 | Low-Ogestrel 28 Day Pack | SY | d2bfe067-3948-4f1e-bfea-f16e1b3fd430 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51862-564-01 | 51862056401 | 1 in 1 BLISTER PACK | Historical | |||||
| 51862-564-06 | 51862056406 | 6 BLISTER PACK in 1 CARTON (51862-564-06) / 1 KIT in 1 BLISTER PACK (51862-564-01) | 6 blister pack | 2016-08-03 | 2027-01-31 | No | No | Current |