Prescription drug · ANDA
Buprenorphine hydrochloride NDC 68083-696
Buprenorphine hydrochloride .324 mg/mL · Injection · Intramuscular, Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-696-05 | 6808306960568083069605 | 5 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.
- NDC on a medical claim
N468083069605followed by a unit qualifier and the quantityPackage 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.
Related NDCs: other Buprenorphine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| buprenorphine hydrochloride | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-4570 | 70518-4570-00 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-4571 | 70518-4571-0070518-4571-02 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 12 mg/1 | TabletSublingual | Advagen Pharma Ltd | 72888-510 | 72888-0510-0172888-0510-02 |
| Buprenorphine Hydrochloride | Buprenorphine hydrochloride .324 mg/mL | InjectionIntramuscular, Intravenous | Somerset Therapeutics, LLC | 70069-027 | 70069-0027-05 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | PAI Holdings, LLC dba PAI Pharma | 0121-1019 | 00121-1019-30 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | PAI Holdings, LLC dba PAI Pharma | 0121-2038 | 00121-2038-30 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | A-S Medication Solutions | 50090-7559 | 50090-7559-00 |
| Buprenorphine Hydrochloride | Buprenorphine hydrochloride .324 mg/mL | InjectionIntramuscular, Intravenous | Par Health USA, LLC | 42023-179 | 42023-0179-05 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Advagen Pharma Ltd | 72888-182 | 72888-0182-3072888-0182-90 |
| buprenorphine hydrochloride | Buprenorphine hydrochloride 8 mg/1 | TabletSublingual | Advagen Pharma Ltd | 72888-183 | 72888-0183-3072888-0183-90 |