NDC 53002-1637
Low-Ogestrel
Norgestrel And Ethinyl Estradiol
Low-Ogestrel is a Kit in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is .
| Product ID | 53002-1637_5a511690-260d-4230-8249-aa1be9ee73cf |
| NDC | 53002-1637 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Low-Ogestrel |
| Generic Name | Norgestrel And Ethinyl Estradiol |
| Dosage Form | Kit |
| Marketing Start Date | 2016-08-03 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA075288 |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Active Ingredient Strength | 0 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 53002-1637-1
1 BLISTER PACK in 1 PACKAGE (53002-1637-1) > 1 KIT in 1 BLISTER PACK
| Marketing Start Date | 2017-09-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 53002-1637-1 [53002163701]
Low-Ogestrel KIT
| Marketing Category | ANDA |
| Application Number | ANDA075288 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-09-01 |
| Inactivation Date | 2020-01-31 |
NDC 53002-1637-6 [53002163706]
Low-Ogestrel KIT
| Marketing Category | ANDA |
| Application Number | ANDA075288 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-09-01 |
| Inactivation Date | 2020-01-31 |
NDC 53002-1637-3 [53002163703]
Low-Ogestrel KIT
| Marketing Category | ANDA |
| Application Number | ANDA075288 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2017-09-01 |
| Inactivation Date | 2020-01-31 |
Drug Details
OpenFDA Data
| SPL SET ID: | d2bfe067-3948-4f1e-bfea-f16e1b3fd430 |
| Manufacturer | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "Low-Ogestrel" or generic name "Norgestrel And Ethinyl Estradiol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 51862-564 | Low-Ogestrel | Norgestrel and Ethinyl Estradiol |
| 53002-1637 | Low-Ogestrel | Norgestrel and Ethinyl Estradiol |
| 0555-9049 | Cryselle | Norgestrel and Ethinyl Estradiol |
| 50090-2183 | Cryselle | Norgestrel and Ethinyl Estradiol |
| 53002-1188 | Cryselle | Norgestrel and Ethinyl Estradiol |
| 70518-1214 | Cryselle | Norgestrel and Ethinyl Estradiol |
| 16714-365 | Elinest | Norgestrel and Ethinyl Estradiol |
| 52544-848 | Ogestrel | Norgestrel and Ethinyl Estradiol |
Trademark Results [Low-Ogestrel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LOW-OGESTREL 75600524 2371732 Live/Registered |
MAYNE PHARMA LLC 1998-12-01 |
 LOW-OGESTREL 74638091 not registered Dead/Abandoned |
G. D. SEARLE & CO. 1995-02-22 |
 LOW-OGESTREL 74191866 not registered Dead/Abandoned |
Syntex (F.P.) Inc. 1991-08-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.