What is NDC 0378-8766?

0378-8766 is the product NDC for Buprenorphine and Naloxone, Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride dihydrate 1 mg/1 film, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate.

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 Buprenorphine and Naloxone?

50 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Buprenorphine and Naloxone NDC 0378-8766

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-8766Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-8766Add 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
0378-8766-93	00378876693	30 POUCH in 1 CARTON (0378-8766-93) / 1 FILM in 1 POUCH (0378-8766-16)Marketed from Apr 17, 2020

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): Buprenorphine and Naloxone
Generic name (nonproprietary): buprenorphine and naloxone
Active ingredients: Buprenorphine hydrochloride — 4 mg/1Naloxone hydrochloride dihydrate — 1 mg/1
Dosage form: Film
Route: Buccal, Sublingual
Labeler: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211785
Marketing start: Apr 17, 2020
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 0378-8766_008d89ec-5bd7-46d9-bc94-9cdc7405f95dSPL ID 008d89ec-5bd7-46d9-bc94-9cdc7405f95dSPL set ID 557d8d4d-8751-431c-b18e-9d5cf23fc579RxCUI 1010600, 1010604, 1307056, 1307061UNII 5Q187997EE, 56W8MW3EN1
Pharmacologic class: Opioid Antagonist; Partial Opioid Agonist

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. Buccal, Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378876693 followed by a unit qualifier and the quantity

Package 00378-8766-93. 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 Jan 15, 2026.

Indications (excerpt from the label)

Buprenorphine and naloxone sublingual film is indicated for treatment of opioid dependence. Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. Buprenorphine and naloxone sublingual film contains buprenorphine, a partial-opioid agonist, and naloxone, an opioid antagonist, and is indicated for treatment of opioid dependence. ( 1 ) Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0378-8766

What is NDC 0378-8766?: 0378-8766 is the product NDC for Buprenorphine and Naloxone, Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride dihydrate 1 mg/1 film, 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?: Buprenorphine and Naloxone.
What is the active ingredient?: Buprenorphine hydrochloride, Naloxone hydrochloride dihydrate.
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 Buprenorphine and Naloxone?: 50 other product NDCs are listed under this name. See all Buprenorphine and Naloxone 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 Buprenorphine and Naloxone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Buprenorphine And Naloxone	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1	TabletSublingual	Ascend Laboratories, LLC	67877-606	67877-0606-3067877-0606-8467877-0606-90
Buprenorphine And Naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1	TabletSublingual	Ascend Laboratories, LLC	67877-607	67877-0607-3067877-0607-8467877-0607-90
Buprenorphine and Naloxone	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride 2 mg/1	Film, SolubleBuccal, Sublingual	Camber Pharmaceuticals, Inc.	31722-481	31722-0481-30
Buprenorphine and Naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1	Film, SolubleBuccal, Sublingual	Camber Pharmaceuticals, Inc.	31722-479	31722-0479-30
Buprenorphine and Naloxone	Buprenorphine hydrochloride 4 mg/1; Naloxone hydrochloride 1 mg/1	Film, SolubleBuccal, Sublingual	Camber Pharmaceuticals, Inc.	31722-480	31722-0480-30
Buprenorphine and Naloxone	Buprenorphine hydrochloride 12 mg/1; Naloxone hydrochloride 3 mg/1	Film, SolubleBuccal, Sublingual	Camber Pharmaceuticals, Inc.	31722-482	31722-0482-30
Buprenorphine and Naloxone	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Unit Dose Solutions, Inc.	87441-001	87441-0001-01
Buprenorphine and Naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1	TabletSublingual	Camber Pharmaceuticals, Inc.	31722-850	31722-0850-30
Buprenorphine and Naloxone	Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1	TabletSublingual	Camber Pharmaceuticals, Inc.	31722-851	31722-0851-30
Buprenorphine and Naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride .5 mg/1	FilmBuccal, Sublingual	Aveva Drug Delivery Systems Inc.	3215-6521	03215-6521-30

All 51 Buprenorphine and Naloxone NDCs

Other NDCs under ANDA 211785

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

FDA NDC Directory listings under ANDA 211785
Product	Strength	Form · route	Labeler	Product NDC
Buprenorphine and Naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1	FilmBuccal, Sublingual	Redpharm Drug	67296-2063
Buprenorphine and Naloxone	Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1	FilmBuccal, Sublingual	Mylan Pharmaceuticals Inc.	0378-8765