Prescription drug · ANDA
Introvale (Levonorgestrel and ethinyl estradiol) NDC 70700-117
Kit · Xiromed, LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70700-117-87 | 7070001178770700011787 | 1 BLISTER PACK in 1 CARTON (70700-117-87) / 1 KIT in 1 BLISTER PACKMarketed from Feb 1, 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)
- Introvale
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Xiromed, LLC.NDC labeler code 70700
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079064
- Marketing start
- Listing expires
- Identifiers
- Product ID 70700-117_824be494-8fdb-e66e-e138-26efa1ed7c4aSPL ID 824be494-8fdb-e66e-e138-26efa1ed7c4aSPL set ID f5bc2427-3a18-e3e6-a058-210688e9c446RxCUI 238019, 748797, 751901, 1020155UPC 0370700117873
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
N470700011787followed by a unit qualifier and the quantityPackage 70700-0117-87. 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)
Introvale ® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Introvale is an estrogen/progestin COC indicated for use by women to prevent pregnancy. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 70700-117
- What is NDC 70700-117?
- 70700-117 is the product NDC for Introvale 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?
- Introvale (Levonorgestrel 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 Introvale?
- 1 other product NDC are listed under this name. See all Introvale NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Introvale products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Introvalelevonorgestrel and ethinyl estradiol tablets | — | Kit | Xiromed LLC | 70700-208 | 70700-0208-88 |