Prescription drug · ANDA
Volnea (Desogestrel and ethinyl estradiol) NDC 63629-2449
Kit · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2449-1 | 63629244901 | 3 BLISTER PACK in 1 CARTON (63629-2449-1) / 1 KIT in 1 BLISTER PACKMarketed from Apr 27, 2021 |
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)
- Volnea
- Generic name (nonproprietary)
- desogestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202689
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-2449_50ece9ce-fedb-4a45-9ac6-e4253fcab02cSPL ID 50ece9ce-fedb-4a45-9ac6-e4253fcab02cSPL set ID 0e65209d-329a-4d31-8afb-24348dc8d7e7RxCUI 248310, 249357, 748797, 759743, 2001756
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
N463629244901followed by a unit qualifier and the quantityPackage 63629-2449-01. 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)
INDICATIONS AND USAGE Volnea™ (desogestrel and ethinyl estradiol and ethinyl estradiol) tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 2 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. TABLE 2 Percentage of women experiencing an unintended pregnancy during the first year of typical use and the fi…
Excerpt only. Read the full label for complete information.
About NDC 63629-2449
- What is NDC 63629-2449?
- 63629-2449 is the product NDC for Volnea kit, listed with the FDA by Bryant Ranch Prepack. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Volnea (Desogestrel and Ethinyl Estradiol).
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Volnea?
- 1 other product NDC are listed under this name. See all Volnea NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Volnea products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Volneadesogestrel and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-122 | 70700-0122-85 |
Other NDCs under ANDA 202689
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 |
|---|---|---|---|---|
| Volneadesogestrel and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-122 |