NDC codes

FDA NDC Directory
Product NDC (as listed)0228-3156Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00228-3156Add 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 NDC11-digit (billing)PackageCopy
0228-3156-030022831560330 TABLET in 1 BOTTLE (0228-3156-03)Marketed from Apr 10, 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)
Buprenorphine
Generic name (nonproprietary)
buprenorphine
Active ingredients
Buprenorphine hydrochloride — 2 mg/1
Dosage form
Tablet
Route
Sublingual
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090819
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Partial Opioid Agonists (Mechanism)
Identifiers
Product ID 0228-3156_db0d877f-2f4d-4cf9-b463-6badf66037a7SPL ID db0d877f-2f4d-4cf9-b463-6badf66037a7SPL set ID 03819118-86f6-4329-adaf-4599e7b71f46RxCUI 351264, 351265UNII 56W8MW3EN1
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. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400228315603 followed by a unit qualifier and the quantity

Package 00228-3156-03. 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 .

Indications (excerpt from the label)

Buprenorphine sublingual tablets are indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablets contain buprenorphine, a partial opioid agonist, and are indicated for the treatment of opioid dependence and is preferred for induction. ( 1 ) Buprenorphine sublingual tablets 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)

Other NDCs under ANDA 090819

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

FDA NDC Directory listings under ANDA 090819
ProductStrengthForm · routeLabelerProduct NDC
BuprenorphineBuprenorphine hydrochloride 8 mg/1TabletSublingualActavis Pharma, Inc.0228-3153
BuprenorphineBuprenorphine hydrochloride 2 mg/1TabletSublingualREMEDYREPACK INC.70518-1557

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