NDC codes

FDA NDC Directory
Product NDC (as listed)65841-654Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65841-0654Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
65841-654-016584106540165841065401100 CAPSULE in 1 BOTTLE (65841-654-01)Marketed from Jan 23, 2009
65841-654-06658410654066584106540630 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

N465841065401 followed by a unit qualifier and the quantity

Package 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 .

Full label on DailyMed (opens in a new tab)

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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Bromocriptine mesylate NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Bromocriptine MesylateBromocriptine mesylate 2.5 mg/1TabletOralAmerican Health Packaging60687-93160687-0931-21
Bromocriptine mesylateBromocriptine mesylate 2.5 mg/1TabletOralREMEDYREPACK INC.70518-462870518-4628-00
Bromocriptine MesylateBromocriptine mesylate 5 mg/1CapsuleOralANI Pharmaceuticals, Inc.70954-95170954-0951-1070954-0951-20
Bromocriptine MesylateBromocriptine mesylate 2.5 mg/1TabletOralANI Pharmaceuticals, Inc.70954-97870954-0978-1070954-0978-20
Bromocriptine mesylateBromocriptine mesylate 2.5 mg/1TabletOralPadagis US LLC0574-010600574-0106-0100574-0106-03
Bromocriptine MesylateBromocriptine mesylate 5 mg/1CapsuleOralMylan Pharmaceuticals Inc.0378-709600378-7096-0100378-7096-93
Bromocriptine mesylateBromocriptine mesylate 5 mg/1CapsuleOralZydus Pharmaceuticals USA Inc.68382-11068382-0110-0168382-0110-06
Bromocriptine mesylateBromocriptine mesylate 2.5 mg/1TabletOralSandoz Inc0781-532500781-5325-0100781-5325-31

Other NDCs under ANDA 078899

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078899
ProductStrengthForm · routeLabelerProduct NDC
Bromocriptine mesylateBromocriptine mesylate 5 mg/1CapsuleOralZydus Pharmaceuticals USA Inc.68382-110

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