Prescription drug · ANDA
Cabergoline NDC 50742-118
Cabergoline .5 mg/1 · Tablet · Oral · Ingenus Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50742-118-08 | 50742011808 | 8 TABLET in 1 BOTTLE (50742-118-08)Marketed from Aug 9, 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)
- Cabergoline
- Generic name (nonproprietary)
- cabergoline
- Active ingredients
- Cabergoline — .5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ingenus Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204735
- Marketing start
- Listing expires
- Other FDA classes
- Ergolines (Chemical structure)
- Identifiers
- Product ID 50742-118_9bcb5111-ddb4-46f6-9318-e4a9d51d9e30SPL ID 9bcb5111-ddb4-46f6-9318-e4a9d51d9e30SPL set ID 57cbd81e-fdb9-4060-80ee-6e8581c463a4RxCUI 199703UNII LL60K9J05TUPC 0350742118083
- Pharmacologic class
- Ergot Derivative
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450742011808followed by a unit qualifier and the quantityPackage 50742-0118-08. 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 .
Indications (excerpt from the label)
Cabergoline tablets are an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. Limitations of Use Avoid use of cabergoline tablets for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions [see Warnings and Precautions (5.4) ] . Cabergoline tablets are an ergot derivative indicated for the treatment of hyperprolactinemic disorders, either idiopathic or due to pituitary adenomas in adults. ( 1 ) Limitations of Use Avoid use of cabergoline tablets for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adve…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204735
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 |
|---|---|---|---|---|
| Cabergoline | Cabergoline .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5834 |