Bromocriptine mesylate NDC 70518-4628

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-4628Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-4628Add 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
70518-4628-0	70518462800	50 POUCH in 1 BOX (70518-4628-0) / 1 TABLET in 1 POUCH (70518-4628-1)Marketed from Apr 24, 2026

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: REMEDYREPACK INC.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077646
Marketing start: Apr 24, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Ergolines (Chemical structure)
Identifiers: Product ID 70518-4628_50764f5e-e4f8-7f34-e063-6294a90a374dSPL ID 50764f5e-e4f8-7f34-e063-6294a90a374dSPL set ID 29827cb6-f8fe-424f-80ef-48f4ef460122RxCUI 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

N470518462800 followed by a unit qualifier and the quantity

Package 70518-4628-00. 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 Apr 27, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hyperprolactinemia-Associated Dysfunctions Bromocriptine mesylate tablets are indicated for the treatment of dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism . Bromocriptine mesylate tablets 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 therapy may be used to reduce the tumor mass prior to surge…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077646

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

FDA NDC Directory listings under ANDA 077646
Product	Strength	Form · route	Labeler	Product NDC
Bromocriptine mesylate	Bromocriptine mesylate 2.5 mg/1	TabletOral	Padagis US LLC	0574-0106