What is NDC 0378-1086?

0378-1086 is the product NDC for Colchicine, Colchicine .6 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, 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 Colchicine?

48 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Colchicine NDC 0378-1086 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-1086Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-1086Add 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
0378-1086-01	0037810860100378108601	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1086-01)Marketed from Nov 25, 2019

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): Colchicine
Generic name (nonproprietary): colchicine
Active ingredients: Colchicine — .6 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209470
Marketing start: Nov 25, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Alkaloids (Chemical structure)
Identifiers: Product ID 0378-1086_9ba74921-d6b7-40a8-aa1e-d7431574a137SPL ID 9ba74921-d6b7-40a8-aa1e-d7431574a137SPL set ID 85acf34c-06c6-40ea-95f4-060d5de99277RxCUI 197541UNII SML2Y3J35TUPC 0303781086936
Pharmacologic class: Alkaloid

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

N400378108601 followed by a unit qualifier and the quantity

Package 00378-1086-01. 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 Apr 1, 2022.

Indications (excerpt from the label)

Colchicine tablets are an alkaloid indicated for: • Prophylaxis and treatment of gout flares in adults ( 1.1 ). • Familial Mediterranean fever (FMF) in adults and children 4 years or older ( 1.2 ). 1.1 Gout Flares Colchicine tablets are indicated for prophylaxis and the treatment of acute gout flares. • Prophylaxis of Gout Flares: Colchicine tablets are indicated for prophylaxis of gout flares. • Treatment of Gout Flares: Colchicine tablets are indicated for treatment of acute gout flares when taken at the first sign of a flare. 1.2 Familial Mediterranean Fever (FMF) Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-1086

What is NDC 0378-1086?: 0378-1086 is the product NDC for Colchicine, Colchicine .6 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Colchicine.
What is the active ingredient?: Colchicine.
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 Colchicine?: 48 other product NDCs are listed under this name. See all Colchicine 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 Colchicine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Colchicine	Colchicine .6 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-687	72189-0687-03
colchicine	Colchicine .6 mg/1	TabletOral	ST. MARY'S MEDICAL PARK PHARMACY	60760-839	60760-0839-10
Colchicine	Colchicine .6 mg/1	CapsuleOral	Micro Labs Limited	42571-341	42571-0341-0142571-0341-1042571-0341-30
Colchicine	Colchicine .6 mg/1	CapsuleOral	Coupler LLC	67046-1634	67046-1634-03
Colchicine	Colchicine .6 mg/1	CapsuleOral	Coupler LLC	67046-0889	67046-0889-03
Colchicine	Colchicine .6 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-099	31722-0099-0131722-0099-1031722-0099-30
Colchicine	Colchicine .6 mg/1	CapsuleOral	Granules Pharmaceutical Inc.	70010-001	70010-0001-0170010-0001-0370010-0001-10
Colchicine	Colchicine .6 mg/1	CapsuleOral	Bryant Ranch Prepack	71335-2703	71335-2703-0171335-2703-0271335-2703-03+5 more
colchicine	Colchicine .6 mg/1	TabletOral	REMEDYREPACK INC.	70518-4000	70518-4000-01
Colchicine	Colchicine .6 mg/1	CapsuleOral	Par Health USA, LLC	0254-0460	00254-0460-01

All 49 Colchicine NDCs