Prescription drug · NDA
levonorgestrel and ethinyl estradiol NDC 42192-623
Kit · Acella Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42192-623-03 | 42192062303 | 3 BLISTER PACK in 1 CARTON (42192-623-03) / 1 KIT in 1 BLISTER PACKMarketed from Aug 21, 2023 | |
| 42192-623-28 | 42192062328 | 1 BLISTER PACK in 1 CARTON (42192-623-28) / 1 KIT in 1 BLISTER PACKMarketed from Aug 21, 2023 |
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)
- levonorgestrel and ethinyl estradiol
- Generic name (nonproprietary)
- levonorgestrel and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- Acella Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208612
- Marketing start
- Listing expires
- Identifiers
- Product ID 42192-623_18a7ed1f-bfc1-476c-9550-77f80f5feeacSPL ID 18a7ed1f-bfc1-476c-9550-77f80f5feeacSPL set ID 167b12a0-cdff-4081-a0a4-164482c239faRxCUI 242297, 2672922, 2672923
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
N442192062303followed by a unit qualifier and the quantityPackage 42192-0623-03. 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)
Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets are progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208612
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 |
|---|---|---|---|---|
| Balcoltralevonorgestrel and ethinyl estradiol | — | Kit | Avion Pharmaceuticals | 75854-602 |