Prescription drug · ANDA
Zumandimine NDC 59651-030
drospirenone and ethinyl estradiol · Kit · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-030-28 | 59651003028 | 1 BLISTER PACK in 1 CARTON (59651-030-28) / 1 KIT in 1 BLISTER PACKMarketed from Mar 26, 2018 | |
| 59651-030-85 | 59651003085 | 3 BLISTER PACK in 1 CARTON (59651-030-85) / 1 KIT in 1 BLISTER PACKMarketed from Mar 26, 2018 | |
| 59651-030-87 | 59651003087 | 1 POUCH in 1 CARTON (59651-030-87) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Mar 26, 2018 | |
| 59651-030-88 | 59651003088 | 3 POUCH in 1 CARTON (59651-030-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACKMarketed from Mar 26, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Zumandimine
- Generic name (nonproprietary)
- drospirenone and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209407
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-030_7cec3990-8d5f-4585-8bbc-fe2556cf69f5SPL ID 7cec3990-8d5f-4585-8bbc-fe2556cf69f5SPL set ID 192ad3b0-9ef2-409d-a851-77712202c45aRxCUI 284207, 748797, 748800, 2045196
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
N459651003028followed by a unit qualifier and the quantityPackage 59651-0030-28. 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)
Zumandimine ® (drospirenone and ethinyl estradiol tablets) are indicated for use by females of reproductive potential to prevent pregnancy. Zumandimine (drospirenone and ethinyl estradiol tablets) is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
Excerpt only. Read the full label for complete information.