NDC codes

FDA NDC Directory
Product NDC (as listed)68382-110Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68382-0110Add 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
68382-110-016838201100168382011001100 CAPSULE in 1 BOTTLE (68382-110-01)Marketed from Jan 23, 2009
68382-110-06683820110066838201100630 CAPSULE in 1 BOTTLE (68382-110-06)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 Pharmaceuticals USA Inc.NDC labeler code 68382
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 68382-110_98e43e82-81ff-465b-a27d-f620b182705cSPL ID 98e43e82-81ff-465b-a27d-f620b182705cSPL set ID d69003ee-0b6f-47a9-834e-ba59c02f566cRxCUI 197412UNII FFP983J3ODUPC 0368382110015
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

N468382011001 followed by a unit qualifier and the quantity

Package 68382-0110-01. 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 .

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 capsule 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 Bromocri…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68382-110

What is NDC 68382-110?
68382-110 is the product NDC for Bromocriptine mesylate, Bromocriptine mesylate 5 mg/1 capsule, listed with the FDA by Zydus Pharmaceuticals USA 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?
Zydus Pharmaceuticals USA Inc., NDC labeler code 68382. 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 Lifesciences Limited65841-65465841-0654-0165841-0654-06
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 Lifesciences Limited65841-654

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in