Prescription drug · ANDA
Buprenorphine Hydrochloride NDC 70069-027
Buprenorphine hydrochloride .324 mg/mL · Injection · Intramuscular, Intravenous · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-027-05 | 70069002705 | 5 VIAL in 1 CARTON (70069-027-05) / 1 mL in 1 VIALMarketed from Feb 11, 2025 |
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
- Somerset Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219302
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 70069-027_abc53fa8-3d75-47b5-bfb1-d61872c1ddb4SPL ID abc53fa8-3d75-47b5-bfb1-d61872c1ddb4SPL set ID 74e40c51-853b-4e7f-b3cb-a27af29e1cbfRxCUI 238129UNII 56W8MW3EN1UPC 0370069027059, 0370069027011
- 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
N470069002705followed by a unit qualifier and the quantityPackage 70069-0027-05. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS: Addiction, Abuse, and Misuse] , reserve buprenorphine hydrochloride injection for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. Buprenorphin…
Excerpt only. Read the full label for complete information.