What is NDC 0378-7096?

0378-7096 is the product NDC for Bromocriptine Mesylate, Bromocriptine mesylate 5 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-7096

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7096Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7096Add 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
0378-7096-01	0037870960100378709601	100 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-7096-01)Marketed from Jul 1, 2013
0378-7096-93	0037870969300378709693	30 CAPSULE in 1 BOTTLE, UNIT-DOSE (0378-7096-93)Marketed from Jun 17, 2013

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 — 5 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077226
Marketing start: Jun 17, 2013
Marketing end: Apr 30, 2027
Other FDA classes: Ergolines (Chemical structure)
Identifiers: Product ID 0378-7096_a4f59939-9590-49d4-907d-eb0919a4715bSPL ID a4f59939-9590-49d4-907d-eb0919a4715bSPL set ID 72d8eefe-c066-41b6-8922-9586f1cf47a1RxCUI 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

N400378709601 followed by a unit qualifier and the quantity

Package 00378-7096-01. 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 Oct 13, 2021.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-7096

What is NDC 0378-7096?: 0378-7096 is the product NDC for Bromocriptine Mesylate, Bromocriptine mesylate 5 mg/1 capsule, listed with the FDA by Mylan Pharmaceuticals 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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	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
Bromocriptine mesylate	Bromocriptine mesylate 2.5 mg/1	TabletOral	Sandoz Inc	0781-5325	00781-5325-0100781-5325-31