Kelnor 1/35
- Product NDC
- 50090-2191
- 11-digit product format
- 500902191
- Labeler code
- 50090
- Product ID
- 50090-2191_a5db2a67-56a5-4c67-a1fc-12ad662b4193
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ethynodiol Diacetate and Ethinyl Estradiol
- Dosage form
- KIT
- Labeler
- A-S Medication Solutions
- Application
- ANDA076785
- Marketing category
- ANDA
- Marketing start
- 2005-06-20
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Kelnor 1/35
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 310228, 748797, 748804, 753483 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-2191-0 | 2023-02-07 | C162847 | 48780-1 | 9d75b9cf-e501-f424-e053-dadaa90a57ce | Kelnor ® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) |
| 50090-2191-0 | 2023-01-30 | C162847 | 48780-1 | 9d75b9cf-e501-f424-e053-dadaa90a57ce | Kelnor ® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) |
| 50090-2191-0 | 2020-02-14 | C162847 | 48780-1 | 9d75b9cf-e501-f424-e053-dadaa90a57ce | Kelnor ® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) |
| 50090-2191-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e501-f424-e053-dadaa90a57ce | Kelnor ® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-2191-0 | Kelnor 1/35 | 1 in 1 KIT | KIT | 1 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-2191-0 | EA - Each | 50090-2191 | edac2872-4521-48ff-b995-5be2b932c02d | 1 | 2019-02-13 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-2191 | KELNOR 1/35 (ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL) KIT [A-S MEDICATION SOLUTIONS] | 12 | Current NDC, Legacy NDC, 1 package rows | 20230208_cfa297a6-1cc7-4751-b8ea-0e57965f1ca9.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 753483 | {21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Kelnor 1/35 28 Day] | BPCK | cfa297a6-1cc7-4751-b8ea-0e57965f1ca9 | 12 |
| 748804 | {21 (ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack | GPCK | cfa297a6-1cc7-4751-b8ea-0e57965f1ca9 | 12 |
| 748804 | Eth estra-Ethyn 0.035-1 MG (21) Oral Tablet / Inert 1 MG (7) Oral Tablet 28 Day Pack | PSN | cfa297a6-1cc7-4751-b8ea-0e57965f1ca9 | 12 |
| 310228 | ethynodiol diacetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet | PSN | cfa297a6-1cc7-4751-b8ea-0e57965f1ca9 | 12 |
| 748797 | inert 1 MG Oral Tablet | PSN | cfa297a6-1cc7-4751-b8ea-0e57965f1ca9 | 12 |
| 753483 | Kelnor 1/35 28 Day Pack | PSN | cfa297a6-1cc7-4751-b8ea-0e57965f1ca9 | 12 |
| 310228 | ethinyl estradiol 0.035 MG / ethynodiol diacetate 1 MG Oral Tablet | SCD | cfa297a6-1cc7-4751-b8ea-0e57965f1ca9 | 12 |
| 748797 | inert ingredients 1 MG Oral Tablet | SCD | cfa297a6-1cc7-4751-b8ea-0e57965f1ca9 | 12 |
| 310228 | ethinyl estradiol 35 MCG / ethynodiol 1 MG Oral Tablet | SY | cfa297a6-1cc7-4751-b8ea-0e57965f1ca9 | 12 |
| 753483 | Kelnor 1/35 28 Day Pack | SY | cfa297a6-1cc7-4751-b8ea-0e57965f1ca9 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50090-2191-0 | 50090219100 | 1 KIT in 1 KIT (50090-2191-0) | 1 kit | 2015-10-26 | 0000-00-00 | No | No | Current |