VyLibra
- Product NDC
- 53002-1777
- 11-digit product format
- 530021777
- Labeler code
- 53002
- Product ID
- 53002-1777_b8da0c3e-bddd-401c-b973-039574a2ffbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norgestimate and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA205449
- Marketing category
- ANDA
- Marketing start
- 2016-07-07
- 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-1777-1 | 2025-01-30 | C162847 | 48780-1 | f386c649-9bd5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 |
| 53002-1777-3 | 2025-01-30 | C162847 | 48780-1 | f386c649-9bd5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 |
| 53002-1777-6 | 2025-01-30 | C162847 | 48780-1 | f386c649-9bd5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 |
| 53002-1777-1 | 2023-06-07 | C162847 | 48780-1 | f386c649-9bd5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 |
| 53002-1777-3 | 2023-06-07 | C162847 | 48780-1 | f386c649-9bd5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 |
| 53002-1777-6 | 2023-06-07 | C162847 | 48780-1 | f386c649-9bd5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 |
| 53002-1777-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-9bd5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 |
| 53002-1777-3 | 2023-01-30 | C162847 | 48780-1 | f386c649-9bd5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 |
| 53002-1777-6 | 2023-01-30 | C162847 | 48780-1 | f386c649-9bd5-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra ® (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989 |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1777 | VYLIBRA (NORGESTIMATE AND ETHINYL ESTRADIOL) KIT [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 5 package rows | 20230609_e5b71df3-d99e-4e2d-a0cf-4c2790a6907d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-1777-1 | 53002177701 | 1 KIT in 1 BLISTER PACK (53002-1777-1) | 1 kit | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-1777-3 | 53002177703 | 3 BLISTER PACK in 1 POUCH (53002-1777-3) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2019-01-01 | 0000-00-00 | No | No | Current |
| 53002-1777-6 | 53002177706 | 6 BLISTER PACK in 1 POUCH (53002-1777-6) > 1 KIT in 1 BLISTER PACK | 6 blister pack | 2019-01-01 | 0000-00-00 | No | No | Current |