Low-Ogestrel
- Product NDC
- 53002-1637
- 11-digit product format
- 530021637
- Labeler code
- 53002
- Product ID
- 53002-1637_5a511690-260d-4230-8249-aa1be9ee73cf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norgestrel and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA075288
- 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-1637-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-3 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-6 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-1 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-3 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-6 | 2023-06-07 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-3 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-6 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-1 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-3 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-6 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
| 53002-1637-6 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-e7df-f424-e053-dadaa90a57ce | Low-Ogestrel ® (Norgestrel and Ethinyl Estradiol Tablets USP, 0.3 mg/0.03 mg) |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1637 | LOW-OGESTREL (NORGESTREL AND ETHINYL ESTRADIOL) KIT [RPK PHARMACEUTICALS, INC.] | 4 | Legacy NDC, 6 package rows | 20230609_d2bfe067-3948-4f1e-bfea-f16e1b3fd430.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 |
|---|
| 53002-1637-1 | 53002163701 | 1 BLISTER PACK in 1 PACKAGE (53002-1637-1) > 1 KIT in 1 BLISTER PACK | 1 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1637-3 | 53002163703 | 3 BLISTER PACK in 1 PACKAGE (53002-1637-3) > 1 KIT in 1 BLISTER PACK | 3 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1637-6 | 53002163706 | 6 BLISTER PACK in 1 PACKAGE (53002-1637-6) > 1 KIT in 1 BLISTER PACK | 6 blister pack | 2017-09-01 | 0000-00-00 | No | No | Current |