Bromocriptine Mesylate NDC 70954-978

NDC codes

FDA NDC Directory

Product NDC (as listed)70954-978Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70954-0978Add 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
70954-978-10	70954097810	30 TABLET in 1 BOTTLE (70954-978-10)Marketed from Jun 15, 2025
70954-978-20	70954097820	100 TABLET in 1 BOTTLE (70954-978-20)Marketed from Jun 15, 2025

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 — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: ANI Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 017962
Marketing start: Jun 15, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Ergolines (Chemical structure)
Identifiers: Product ID 70954-978_009f6f28-14a8-4d34-a24c-b09e90572739SPL ID 009f6f28-14a8-4d34-a24c-b09e90572739SPL set ID 17f3a343-1782-4799-95ba-31dfe93be2cfRxCUI 197411, 197412UNII FFP983J3ODUPC 0370954978107, 0370954978206
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

N470954097810 followed by a unit qualifier and the quantity

Package 70954-0978-10. 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 Jul 27, 2026.

Indications (excerpt from the label)

Bromocriptine mesylate is an ergot derivative indicated for the treatment of: Hyperprolactinemia-associated dysfunction including amenorrhea with or without galactorrhea, infertility, or hypogonadism in adults (1.1) Prolactin-secreting adenomas in adults and pediatric patients 11 years of age and older (1.2). Acromegaly in adults (1.3). Signs and symptoms of idiopathic Parkinson’s disease or postencephalitic parkinsonism in adults (1.4). Limitations of Use Avoid use of bromocriptine mesylate for the inhibition or suppression of postpartum physiologic lactation because of the risk of serious adverse reactions (1.1, 5.4) 1.1 Hyperprolactinemia-Associated Dysfunction Bromocriptine mesylate is i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 017962

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

FDA NDC Directory listings under NDA 017962
Product	Strength	Form · route	Labeler	Product NDC
Bromocriptine Mesylate	Bromocriptine mesylate 5 mg/1	CapsuleOral	ANI Pharmaceuticals, Inc.	70954-951
Bromocriptine Mesylate	Bromocriptine mesylate 2.5 mg/1	TabletOral	American Health Packaging	60687-931