Prescription drug · ANDA
Bromocriptine mesylate NDC 65841-654
Bromocriptine mesylate 5 mg/1 · Capsule · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-654-01 | 6584106540165841065401 | 100 CAPSULE in 1 BOTTLE (65841-654-01)Marketed from Jan 23, 2009 | |
| 65841-654-06 | 6584106540665841065406 | 30 CAPSULE in 1 BOTTLE (65841-654-06)Marketed from Jan 23, 2009 |
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)
- Bromocriptine mesylate
- Generic name (nonproprietary)
- bromocriptine mesylate
- Active ingredients
- Bromocriptine mesylate — 5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 65841
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078899
- Marketing start
- Listing expires
- Other FDA classes
- Ergolines (Chemical structure)
- Identifiers
- Product ID 65841-654_f9589272-83ad-497b-8a10-42ff73384d25SPL ID f9589272-83ad-497b-8a10-42ff73384d25SPL set ID 97e7e051-ff64-4381-a869-6c1c364ad822RxCUI 197412UNII FFP983J3OD
- 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
N465841065401followed by a unit qualifier and the quantityPackage 65841-0654-01. 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 .
About NDC 65841-654
- What is NDC 65841-654?
- 65841-654 is the product NDC for Bromocriptine mesylate, Bromocriptine mesylate 5 mg/1 capsule, listed with the FDA by Zydus Lifesciences Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bromocriptine mesylate.
- What is the active ingredient?
- Bromocriptine mesylate.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 65841. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bromocriptine mesylate?
- 8 other product NDCs are listed under this name. See all Bromocriptine mesylate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bromocriptine mesylate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bromocriptine Mesylate | Bromocriptine mesylate 2.5 mg/1 | TabletOral | American Health Packaging | 60687-931 | 60687-0931-21 |
| Bromocriptine mesylate | Bromocriptine mesylate 2.5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4628 | 70518-4628-00 |
| Bromocriptine Mesylate | Bromocriptine mesylate 5 mg/1 | CapsuleOral | ANI Pharmaceuticals, Inc. | 70954-951 | 70954-0951-1070954-0951-20 |
| Bromocriptine Mesylate | Bromocriptine mesylate 2.5 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-978 | 70954-0978-1070954-0978-20 |
| Bromocriptine mesylate | Bromocriptine mesylate 2.5 mg/1 | TabletOral | Padagis US LLC | 0574-0106 | 00574-0106-0100574-0106-03 |
| Bromocriptine Mesylate | Bromocriptine mesylate 5 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-7096 | 00378-7096-0100378-7096-93 |
| Bromocriptine mesylate | Bromocriptine mesylate 5 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 68382-110 | 68382-0110-0168382-0110-06 |
| Bromocriptine mesylate | Bromocriptine mesylate 2.5 mg/1 | TabletOral | Sandoz Inc | 0781-5325 | 00781-5325-0100781-5325-31 |
Other NDCs under ANDA 078899
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 |
|---|---|---|---|---|
| Bromocriptine mesylate | Bromocriptine mesylate 5 mg/1 | CapsuleOral | Zydus Pharmaceuticals USA Inc. | 68382-110 |