Prescription drug · ANDA
Drospirenone And Ethinyl Estradiol NDC 67296-2286
Kit · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-2286-3 | 6729622860367296228603 | 3 POUCH in 1 CARTON (67296-2286-3) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK * 21 TABLET in 1 BLISTER PACK (68180-912-74) * 7 TABLET in 1 BLISTER PACK (68180-913-74)Marketed from Apr 15, 2022 |
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
- Redpharm DrugNDC labeler code 67296
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201663
- Marketing start
- Listing expires
- Identifiers
- Product ID 67296-2286_57d1d72f-b7f6-49ca-e063-6294a90a5d7eSPL ID 57d1d72f-b7f6-49ca-e063-6294a90a5d7eSPL set ID 57d1d945-9fc9-4e79-e063-6294a90a738aRxCUI 284207, 748797, 748800
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
N467296228603followed by a unit qualifier and the quantityPackage 67296-2286-03. 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 tablet USP is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Drospirenone and ethinyl estradiol tablet USP is indicated for use by females of reproductive potential to prevent pregnancy.
Excerpt only. Read the full label for complete information.
About NDC 67296-2286
- What is NDC 67296-2286?
- 67296-2286 is the product NDC for Drospirenone And Ethinyl Estradiol kit, listed with the FDA by Redpharm Drug. 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?
- Redpharm Drug, NDC labeler code 67296. 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 | 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 |
| drospirenone and ethinyl estradiol | — | Kit | A-S Medication Solutions | 50090-2594 | 50090-2594-00 |
Other NDCs under ANDA 201663
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 | Lupin Pharmaceuticals, Inc. | 68180-868 |