What is NDC 0781-5325?

0781-5325 is the product NDC for Bromocriptine mesylate, Bromocriptine mesylate 2.5 mg/1 tablet, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bromocriptine mesylate NDC 0781-5325

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-5325Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-5325Add 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 NDC	11-digit (billing)	Package	Copy
0781-5325-01	0078153250100781532501	100 TABLET in 1 BOTTLE (0781-5325-01)Marketed from Jan 13, 1998
0781-5325-31	0078153253100781532531	30 TABLET in 1 BOTTLE (0781-5325-31)Marketed from Jan 13, 1998

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): Bromocriptine mesylate
Generic name (nonproprietary): bromocriptine mesylate
Active ingredients: Bromocriptine mesylate — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074631
Marketing start: Jan 13, 1998
Listing expires: Dec 31, 2026
Other FDA classes: Ergolines (Chemical structure)
Identifiers: Product ID 0781-5325_9767701b-743a-406f-8c25-d97a6ef29aa8SPL ID 9767701b-743a-406f-8c25-d97a6ef29aa8SPL set ID c43c300d-8aec-4020-984a-42c1a917c08fRxCUI 197411UNII 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

N400781532501 followed by a unit qualifier and the quantity

Package 00781-5325-01. 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 Jun 30, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate tablets, USP are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism. Bromocriptine mesylate tablets, USP treatment is indicated in patients with prolactin-secreting adenomas, which may be the basic underlying endocrinopathy contributing to the above clinical presentations. Reduction in tumor size has been demonstrated in both male and female patients with macroadenomas. In cases where adenectomy is elected, a course of bromocriptine mesylate tablets, USP therapy may be used to reduce the tumor mass p…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-5325

What is NDC 0781-5325?: 0781-5325 is the product NDC for Bromocriptine mesylate, Bromocriptine mesylate 2.5 mg/1 tablet, listed with the FDA by Sandoz Inc. 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?: Sandoz Inc, NDC labeler code 0781. 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
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 Lifesciences Limited	65841-654	65841-0654-0165841-0654-06
Bromocriptine mesylate	Bromocriptine mesylate 5 mg/1	CapsuleOral	Zydus Pharmaceuticals USA Inc.	68382-110	68382-0110-0168382-0110-06