Buprenorphine NDC 3215-1523

NDC codes

FDA NDC Directory

Product NDC (as listed)3215-1523Labeler and product segments. Claims need a package NDC.

Product NDC at billing width03215-1523Add 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
3215-1523-04	03215152304	4 POUCH in 1 CARTON (3215-1523-04) / 1 PATCH in 1 POUCH / 168 h in 1 PATCHMarketed from Nov 1, 2023

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
Generic name (nonproprietary): buprenorphine
Active ingredients: Buprenorphine — 10 ug/h
Dosage form: Patch, Extended release
Route: Transdermal
Labeler: Aveva Drug Delivery Systems Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210272
Marketing start: Nov 1, 2023
Listing expires: Dec 31, 2027
DEA schedule: CIII
Other FDA classes: Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 3215-1523_509150ac-3394-c793-e063-6294a90ab2eeSPL ID 509150ac-3394-c793-e063-6294a90ab2eeSPL set ID 1aae9b13-7431-42ef-8558-14a2325820e6RxCUI 904870, 904876, 904880, 1432969, 1542997UNII 40D3SCR4GZ
Pharmacologic class: 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. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N403215152304 followed by a unit qualifier and the quantity

Package 03215-1523-04. 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 28, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Buprenorphine transde…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210272

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

FDA NDC Directory listings under ANDA 210272
Product	Strength	Form · route	Labeler	Product NDC
Buprenorphine	Buprenorphine 15 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-375
Buprenorphine	Buprenorphine 7.5 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-373
Buprenorphine	Buprenorphine 10 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-374
Buprenorphine	Buprenorphine 5 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-372
Buprenorphine	Buprenorphine 15 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-1524
Buprenorphine	Buprenorphine 5 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-1521
Buprenorphine	Buprenorphine 7.5 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-1522
Buprenorphine	Buprenorphine 20 ug/h	Patch, Extended releaseTransdermal	INGENUS PHARMACEUTICALS, LLC	50742-376
Buprenorphine	Buprenorphine 20 ug/h	Patch, Extended releaseTransdermal	Aveva Drug Delivery Systems Inc.	3215-1525