Prescription drug · ANDA
Altavera NDC 63629-2343
levonorgestrel and ethinyl estradiol · Kit · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2343-1 | 63629234301 | 3 CARTON in 1 CARTON (63629-2343-1) / 1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACKMarketed from Jan 1, 2018 |
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)
- Altavera
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079102
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-2343_bea980c0-6724-4cc5-8018-26e87a565dd0SPL ID bea980c0-6724-4cc5-8018-26e87a565dd0SPL set ID c607816d-0da9-4960-9723-69f28aa3f2f2RxCUI 238019, 748797, 748878, 1006065
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
N463629234301followed by a unit qualifier and the quantityPackage 63629-2343-01. 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 Altavera is indicated for use by females of reproductive potential to prevent pregnancy.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079102
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 |
|---|---|---|---|---|
| Altaveralevonorgestrel and ethinyl estradiol | — | Kit | Xiromed, LLC. | 70700-116 |