NDC codes

FDA NDC Directory
Product NDC (as listed)42858-502Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42858-0502Add 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
42858-502-03428580502034285805020330 TABLET in 1 BOTTLE (42858-502-03)Marketed from Oct 25, 2017

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
Generic name (nonproprietary)
buprenorphine
Active ingredients
Buprenorphine hydrochloride — 8 mg/1
Dosage form
Tablet
Route
Sublingual
Labeler
Rhodes Pharmaceuticals LLCNDC labeler code 42858
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207276
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Partial Opioid Agonists (Mechanism)
Identifiers
Product ID 42858-502_5f1402cd-d222-4604-bef0-daa2b15bb4a8SPL ID 5f1402cd-d222-4604-bef0-daa2b15bb4a8SPL set ID da90618a-5621-4b15-bc48-9dcc631418deRxCUI 351264, 351265UNII 56W8MW3EN1UPC 0342858502030
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

N442858050203 followed by a unit qualifier and the quantity

Package 42858-0502-03. 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 are 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 are 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)

About NDC 42858-502

What is NDC 42858-502?
42858-502 is the product NDC for Buprenorphine, Buprenorphine hydrochloride 8 mg/1 tablet, listed with the FDA by Rhodes Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Buprenorphine.
What is the active ingredient?
Buprenorphine hydrochloride.
Who is the labeler?
Rhodes Pharmaceuticals LLC, NDC labeler code 42858. 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?
53 other product NDCs are listed under this name. See all Buprenorphine 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
BuprenorphineBuprenorphine hydrochloride 8 mg/1TabletSublingualUnit Dose Solutions, Inc.87441-08287441-0082-01
BuprenorphineBuprenorphine hydrochloride 2 mg/1TabletSublingualUnit Dose Solutions, Inc.87441-01187441-0011-01
BuprenorphineBuprenorphine hydrochloride 2 mg/1TabletSublingualAvPAK50268-12850268-0128-15
BuprenorphineBuprenorphine hydrochloride 8 mg/1TabletSublingualAvPAK50268-12950268-0129-15
BuprenorphineBuprenorphine 5 ug/hPatch, Extended releaseTransdermalAveva Drug Delivery Systems Inc.3215-152103215-1521-04
BuprenorphineBuprenorphine 7.5 ug/hPatch, Extended releaseTransdermalAveva Drug Delivery Systems Inc.3215-152203215-1522-04
BuprenorphineBuprenorphine 10 ug/hPatch, Extended releaseTransdermalAveva Drug Delivery Systems Inc.3215-152303215-1523-04
BuprenorphineBuprenorphine 15 ug/hPatch, Extended releaseTransdermalAveva Drug Delivery Systems Inc.3215-152403215-1524-04
BuprenorphineBuprenorphine 20 ug/hPatch, Extended releaseTransdermalAveva Drug Delivery Systems Inc.3215-152503215-1525-04
BuprenorphineBuprenorphine 5 ug/hPatch, Extended releaseTransdermalINGENUS PHARMACEUTICALS, LLC50742-37250742-0372-04

All 54 Buprenorphine NDCs

Other NDCs under ANDA 207276

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

FDA NDC Directory listings under ANDA 207276
ProductStrengthForm · routeLabelerProduct NDC
BuprenorphineBuprenorphine hydrochloride 2 mg/1TabletSublingualRhodes Pharmaceuticals LLC42858-501
BuprenorphineBuprenorphine hydrochloride 8 mg/1TabletSublingualA-S Medication Solutions50090-5805
BuprenorphineBuprenorphine hydrochloride 2 mg/1TabletSublingualClinical Solutions Wholesale, LLC58118-0501
BuprenorphineBuprenorphine hydrochloride 8 mg/1TabletSublingualClinical Solutions Wholesale, LLC58118-0502
BuprenorphineBuprenorphine hydrochloride 2 mg/1TabletSublingualAmerican Health Packaging60687-481
BuprenorphineBuprenorphine hydrochloride 8 mg/1TabletSublingualAmerican Health Packaging60687-492
BuprenorphineBuprenorphine hydrochloride 2 mg/1TabletSublingualBryant Ranch Prepack63629-9475
BuprenorphineBuprenorphine hydrochloride 2 mg/1TabletSublingualBryant Ranch Prepack71335-0950
BuprenorphineBuprenorphine hydrochloride 8 mg/1TabletSublingualBryant Ranch Prepack71335-1154
BuprenorphineBuprenorphine hydrochloride 2 mg/1TabletSublingualBryant Ranch Prepack72162-1344
BuprenorphineBuprenorphine hydrochloride 8 mg/1TabletSublingualBryant Ranch Prepack72162-1345
BuprenorphineBuprenorphine hydrochloride 2 mg/1TabletSublingualUnit Dose Solutions, Inc.87441-011
BuprenorphineBuprenorphine hydrochloride 8 mg/1TabletSublingualUnit Dose Solutions, Inc.87441-082

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