Prescription drug · ANDA
Cabergoline NDC 0093-5420
Cabergoline .5 mg/1 · Tablet · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-5420-88 | 0009354208800093542088 | 1 BOTTLE in 1 CARTON (0093-5420-88) / 8 TABLET in 1 BOTTLEMarketed from Mar 7, 2007 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077750
- Marketing start
- Listing expires
- Other FDA classes
- Ergolines (Chemical structure)
- Identifiers
- Product ID 0093-5420_ee38a597-4dd9-4b40-b168-97e919ead1c7SPL ID ee38a597-4dd9-4b40-b168-97e919ead1c7SPL set ID 74b61e8a-7ae9-4996-85ec-df23c56de16fRxCUI 199703UNII LL60K9J05T
- 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
N400093542088followed by a unit qualifier and the quantityPackage 00093-5420-88. 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 advers…
Excerpt only. Read the full label for complete information.
About NDC 0093-5420
- What is NDC 0093-5420?
- 0093-5420 is the product NDC for Cabergoline, Cabergoline .5 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cabergoline.
- What is the active ingredient?
- Cabergoline.
- Who is the labeler?
- Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cabergoline?
- 11 other product NDCs are listed under this name. See all Cabergoline NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cabergoline products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cabergoline | Cabergoline .5 mg/1 | TabletOral | Cranbury Pharmaceuticals, LLC | 27808-315 | 27808-0315-01 |
| Cabergoline | Cabergoline .5 mg/1 | TabletOral | Somerset Therapeutics, LLC | 70069-824 | 70069-0824-08 |
| Cabergoline | Cabergoline .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7642 | 50090-7642-00 |
| Cabergoline | Cabergoline .5 mg/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-2693 | 69238-2693-01 |
| Cabergoline | Cabergoline .5 mg/1 | TabletOral | SOLA Pharmaceuticals, LLC | 70512-860 | 70512-0860-08 |
| Cabergoline | Cabergoline .5 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-823 | 23155-0823-73 |
| Cabergoline | Cabergoline .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6596 | 50090-6596-00 |
| Cabergoline | Cabergoline .5 mg/1 | TabletOral | A-S Medication Solutions | 50090-5834 | 50090-5834-00 |
| Cabergoline | Cabergoline .5 mg/1 | TabletOral | Ingenus Pharmaceuticals, LLC | 50742-118 | 50742-0118-08 |
| Cabergoline | Cabergoline .5 mg/1 | TabletOral | Mylan Pharmaceuticals Inc. | 59762-1005 | 59762-1005-01 |
Other NDCs under ANDA 077750
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 | 50090-3157 |