What is NDC 0378-6955?

0378-6955 is the product NDC for Bexarotene, Bexarotene 75 mg/1 capsule, liquid filled, 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 Bexarotene?

7 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Bexarotene NDC 0378-6955 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-6955Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-6955Add 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
0378-6955-01	00378695501	100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0378-6955-01)Marketed from Jul 9, 2015

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): Bexarotene
Generic name (nonproprietary): bexarotene
Active ingredients: Bexarotene — 75 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203174
Marketing start: Jul 9, 2015
Listing expires: Dec 31, 2027
Other FDA classes: Retinoids (Chemical structure)
Identifiers: Product ID 0378-6955_6c9b41f4-421f-4ebf-8219-b68e68f75574SPL ID 6c9b41f4-421f-4ebf-8219-b68e68f75574
Pharmacologic class: Retinoid

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

N400378695501 followed by a unit qualifier and the quantity

Package 00378-6955-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0378-6955

What is NDC 0378-6955?: 0378-6955 is the product NDC for Bexarotene, Bexarotene 75 mg/1 capsule, liquid filled, 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?: Bexarotene.
What is the active ingredient?: Bexarotene.
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 Bexarotene?: 7 other product NDCs are listed under this name. See all Bexarotene 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 Bexarotene NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Bexarotene	Bexarotene 75 mg/1	CapsuleOral	Camber Pharmaceuticals, Inc.	31722-380	31722-0380-01
Bexarotene	Bexarotene 75 mg/1	CapsuleOral	AvKARE	42291-072	42291-0072-01
Bexarotene	Bexarotene 10 mg/g	GelTopical	Amneal Pharmaceuticals NY LLC	69238-2088	69238-2088-06
bexarotene	Bexarotene 75 mg/1	Capsule, Liquid filledOral	Actavis Pharma, Inc.	0591-2832	00591-2832-01
Bexarotene	Bexarotene 75 mg/1	CapsuleOral	Amneal Pharmaceuticals NY LLC	69238-1250	69238-1250-01
Bexarotene	Bexarotene 75 mg/1	CapsuleOral	Upsher-Smith Laboratories, Inc.	0832-0285	00832-0285-00
Bexarotene	Bexarotene 75 mg/1	Capsule, Liquid filledOral	ANI Pharmaceuticals, Inc.	43975-315	43975-0315-10