Prescription drug · ANDA
Mono-Linyah (Norgestimate and ethinyl estradiol) NDC 50090-4881
Kit · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-4881-0 | 5009048810050090488100 | 1 KIT in 1 KIT (50090-4881-0)Marketed from Feb 11, 2020 |
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)
- Mono-Linyah
- Generic name (nonproprietary)
- norgestimate and ethinyl estradiol
- Dosage form
- Kit
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090523
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-4881_8599c5bf-cb1a-4e7a-ac4f-c874766d0983SPL ID 8599c5bf-cb1a-4e7a-ac4f-c874766d0983SPL set ID 2ec8f18f-297c-405f-b191-a40767366badRxCUI 240128, 748797, 749860, 1365899
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
N450090488100followed by a unit qualifier and the quantityPackage 50090-4881-00. 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)
Mono-Linyah is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraceptive Mono-Linyah tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies ( 14 )] .
Excerpt only. Read the full label for complete information.
About NDC 50090-4881
- What is NDC 50090-4881?
- 50090-4881 is the product NDC for Mono-Linyah kit, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mono-Linyah (Norgestimate and ethinyl estradiol).
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mono-Linyah?
- 2 other product NDCs are listed under this name. See all Mono-Linyah NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Mono-Linyah products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Mono-Linyahnorgestimate and ethinyl estradiol | — | Kit | Northstar Rx LLC | 16714-360 | 16714-0360-0116714-0360-0216714-0360-03+1 more |
| Mono-Linyahnorgestimate and ethinyl estradiol | — | Kit | Redpharm Drug | 67296-2329 | 67296-2329-08 |
Other NDCs under ANDA 090523
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 |
|---|---|---|---|---|
| Mono-Linyahnorgestimate and ethinyl estradiol | — | Kit | Northstar Rx LLC | 16714-360 |
| Mono-Linyahnorgestimate and ethinyl estradiol | — | Kit | Redpharm Drug | 67296-2329 |
| Nymyonorgestimate and ethinyl estradiol | — | Kit | Mayne Pharma Inc. | 51862-645 |