NDC codes

FDA NDC Directory
Product NDC (as listed)68083-696Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68083-0696Add 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
68083-696-0568083069605680830696055 VIAL in 1 CARTON (68083-696-05) / 1 mL in 1 VIALMarketed from Oct 15, 2026

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 hydrochloride
Generic name (nonproprietary)
buprenorphine hydrochloride
Active ingredients
Buprenorphine hydrochloride — .324 mg/mL
Dosage form
Injection
Route
Intramuscular, Intravenous
Labeler
Gland Pharma LimitedNDC labeler code 68083
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 221145
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Partial Opioid Agonists (Mechanism)
Identifiers
Product ID 68083-696_47e07da7-bfd9-42ea-89dd-b814f546add3SPL ID 47e07da7-bfd9-42ea-89dd-b814f546add3
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N468083069605 followed by a unit qualifier and the quantity

Package 68083-0696-05. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68083-696

What is NDC 68083-696?
68083-696 is the product NDC for Buprenorphine hydrochloride, Buprenorphine hydrochloride .324 mg/mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Buprenorphine hydrochloride.
What is the active ingredient?
Buprenorphine hydrochloride.
Who is the labeler?
Gland Pharma Limited, NDC labeler code 68083. 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 hydrochloride?
12 other product NDCs are listed under this name. See all Buprenorphine hydrochloride 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 hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
buprenorphine hydrochlorideBuprenorphine hydrochloride 2 mg/1TabletSublingualREMEDYREPACK INC.70518-457070518-4570-00
buprenorphine hydrochlorideBuprenorphine hydrochloride 8 mg/1TabletSublingualREMEDYREPACK INC.70518-457170518-4571-0070518-4571-02
buprenorphine hydrochlorideBuprenorphine hydrochloride 12 mg/1TabletSublingualAdvagen Pharma Ltd72888-51072888-0510-0172888-0510-02
Buprenorphine HydrochlorideBuprenorphine hydrochloride .324 mg/mLInjectionIntramuscular, IntravenousSomerset Therapeutics, LLC70069-02770069-0027-05
buprenorphine hydrochlorideBuprenorphine hydrochloride 2 mg/1TabletSublingualPAI Holdings, LLC dba PAI Pharma0121-101900121-1019-30
buprenorphine hydrochlorideBuprenorphine hydrochloride 8 mg/1TabletSublingualPAI Holdings, LLC dba PAI Pharma0121-203800121-2038-30
buprenorphine hydrochlorideBuprenorphine hydrochloride 8 mg/1TabletSublingualA-S Medication Solutions50090-755950090-7559-00
Buprenorphine HydrochlorideBuprenorphine hydrochloride .324 mg/mLInjectionIntramuscular, IntravenousPar Health USA, LLC42023-17942023-0179-05
buprenorphine hydrochlorideBuprenorphine hydrochloride 2 mg/1TabletSublingualAdvagen Pharma Ltd72888-18272888-0182-3072888-0182-90
buprenorphine hydrochlorideBuprenorphine hydrochloride 8 mg/1TabletSublingualAdvagen Pharma Ltd72888-18372888-0183-3072888-0183-90

All 13 Buprenorphine hydrochloride NDCs

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