buprenorphine transdermal system (buprenorphine) NDC 47781-419

NDC codes

FDA NDC Directory

Product NDC (as listed)47781-419Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47781-0419Add 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
47781-419-04	47781041904	4 POUCH in 1 CARTON (47781-419-04) / 1 PATCH in 1 POUCH (47781-419-11) / 168 h in 1 PATCHMarketed from Aug 29, 2022

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): buprenorphine transdermal system
Generic name (nonproprietary): buprenorphine
Active ingredients: Buprenorphine — 15 ug/h
Dosage form: Patch, Extended release
Route: Transdermal
Labeler: Alvogen Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207490
Marketing start: May 17, 2022
Marketing end: Jan 31, 2027
DEA schedule: CIII
Other FDA classes: Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 47781-419_7f83c8aa-7590-e2fe-4998-55323eadd112SPL ID 7f83c8aa-7590-e2fe-4998-55323eadd112SPL set ID 315284b8-32ab-d34a-ea02-f501c6131bccRxCUI 904870, 904876, 904880, 1432969UNII 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

N447781041904 followed by a unit qualifier and the quantity

Package 47781-0419-04. 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 Sep 12, 2025. 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 extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Limitations of Use Because of the risks of addiction, abuse and misuse with opioids, which can occur at any dosage or duration, and because of the greater risk of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions ( 5.1 )] , reserve buprenorphine transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or w…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 207490

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

FDA NDC Directory listings under ANDA 207490
Product	Strength	Form · route	Labeler	Product NDC
buprenorphine transdermal systembuprenorphine	Buprenorphine 20 ug/h	Patch, Extended releaseTransdermal	Alvogen Inc.	47781-408
buprenorphine transdermal systembuprenorphine	Buprenorphine 5 ug/h	Patch, Extended releaseTransdermal	Alvogen Inc.	47781-406
buprenorphine transdermal systembuprenorphine	Buprenorphine 10 ug/h	Patch, Extended releaseTransdermal	Alvogen Inc.	47781-407
buprenorphine transdermal systembuprenorphine	Buprenorphine 20 ug/h	Patch, Extended releaseTransdermal	LTS Therapy Systems, LLC	58064-408