Prescription drug · ANDA
drospirenone and ethinyl estradiol NDC 50090-2594
Kit · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-2594-0 | 5009025940050090259400 | 1 KIT in 1 KIT (50090-2594-0)Marketed from Nov 4, 2016 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- drospirenone and ethinyl estradiol
- Generic name (nonproprietary)
- drospirenone and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204296
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-2594_5084730b-7ef0-4c7a-aee4-5cc8f430b768SPL ID 5084730b-7ef0-4c7a-aee4-5cc8f430b768SPL set ID 9b1f944b-b05b-4ab0-bcf6-42f426b07c45RxCUI 630734, 748797, 748798
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N450090259400followed by a unit qualifier and the quantityPackage 50090-2594-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Drospirenone and ethinyl estradiol tablets are a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: • Prevent pregnancy. ( 1.1 ) • Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. ( 1.2 ) • Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. ( 1.3 ) 1.1 Oral Contraceptive Drospirenone and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) …
Excerpt only. Read the full label for complete information.
About NDC 50090-2594
- What is NDC 50090-2594?
- 50090-2594 is the product NDC for drospirenone and ethinyl estradiol kit, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- drospirenone and ethinyl estradiol.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for drospirenone and ethinyl estradiol?
- 12 other product NDCs are listed under this name. See all drospirenone and ethinyl estradiol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other drospirenone and ethinyl estradiol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Drospirenone And Ethinyl Estradiol | — | Kit | Apotex Corp. | 60505-4897 | 60505-4897-08 |
| Drospirenone and Ethinyl Estradiol | — | Kit | NorthStar Rx LLC | 72603-875 | 72603-0875-03 |
| Drospirenone And Ethinyl Estradiol | — | Kit | Naari Pte. Limited | 79929-019 | 79929-0019-07 |
| Drospirenone And Ethinyl Estradiol | — | Kit | Redpharm Drug | 67296-2286 | 67296-2286-03 |
| Drospirenone And Ethinyl Estradiol | — | Kit | Lupin Pharmaceuticals, Inc. | 68180-868 | 68180-0868-73 |
| Drospirenone and Ethinyl Estradiol | — | Kit | Camber Pharmaceuticals, Inc. | 31722-945 | 31722-0945-3131722-0945-32 |
| Drospirenone and ethinyl estradiol | — | Kit | Camber Pharmaceuticals, Inc. | 31722-934 | 31722-0934-3131722-0934-32 |
| drospirenone and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-2494 | 50090-2494-00 |
| drospirenone and ethinyl estradiol | — | Kit | Glenmark Pharmaceuticals Inc., USA | 68462-733 | 68462-0733-29 |
| Drospirenone And Ethinyl Estradiol | — | Kit | Mylan Pharmaceuticals Inc. | 0378-7300 | 00378-7300-53 |
Other NDCs under ANDA 204296
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| drospirenone and ethinyl estradiol | — | Kit | Glenmark Pharmaceuticals Inc., USA | 68462-720 |
| drospirenone and ethinyl estradiol | — | Kit | Proficient Rx LP | 71205-144 |