Prescription drug · ANDA
Vestura NDC 0480-4000
drospirenone and ethinyl estradiol · Kit · Teva Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0480-4000-62 | 00480400062 | 3 BLISTER PACK in 1 CARTON (0480-4000-62) / 1 KIT in 1 BLISTER PACK (0480-4000-28) * 24 TABLET in 1 BLISTER PACK (0480-3629-11) * 4 TABLET in 1 BLISTER PACK (0480-7892-22)Marketed from Nov 6, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Vestura
- Generic name (nonproprietary)
- drospirenone and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Teva Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078833
- Marketing start
- Listing expires
- Identifiers
- Product ID 0480-4000_894e556a-f100-4683-8c4a-3a0944fb96e0SPL ID 894e556a-f100-4683-8c4a-3a0944fb96e0SPL set ID c6f63cc0-11b0-4320-a9ef-5bd5c9b16fd5RxCUI 630734, 748797, 748798, 1233850
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
N400480400062followed by a unit qualifier and the quantityPackage 00480-4000-62. 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)
Vestura is 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 Vestura ® (drospirenone and ethinyl estradiol) tablets are indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Vestura is also indicated for …
Excerpt only. Read the full label for complete information.