Prescription drug · ANDA
Valtya 1/50 NDC 70700-305
ethynodiol diacetate and ethinyl estradiol · Kit · Xiromed LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-305-85 | 7070003058570700030585 | 3 POUCH in 1 CARTON (70700-305-85) / 1 BLISTER PACK in 1 POUCH (70700-305-84) / 1 KIT in 1 BLISTER PACKMarketed from Jan 29, 2025 |
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)
- Valtya 1/50
- Generic name (nonproprietary)
- ethynodiol diacetate and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Xiromed LLCNDC labeler code 70700
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204704
- Marketing start
- Listing expires
- Identifiers
- Product ID 70700-305_e86c45c6-b94e-8227-79ad-3c1cdf3bff92SPL ID e86c45c6-b94e-8227-79ad-3c1cdf3bff92SPL set ID 1aff28b0-93eb-5e44-9164-d76ffd08cd59RxCUI 315096, 748797, 748806, 2704562
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
N470700030585followed by a unit qualifier and the quantityPackage 70700-0305-85. 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 Valtya 1/50 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptive products such as Valtya 1/50, which contain 50 mcg of estrogen, should not be used unless medically indicated. Oral contraceptives are highly effective. Table 1 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 and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. Tabl…
Excerpt only. Read the full label for complete information.
About NDC 70700-305
- What is NDC 70700-305?
- 70700-305 is the product NDC for Valtya 1/50 kit, listed with the FDA by Xiromed LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Valtya 1/50 (Ethynodiol diacetate and ethinyl estradiol).
- Who is the labeler?
- Xiromed LLC, NDC labeler code 70700. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Valtya 1/50?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 204704
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 |
|---|---|---|---|---|
| Ethynodiol Diacetate And Ethinyl Estradiol | — | Kit | Mylan Pharmaceuticals Inc. | 0378-7306 |