Prescription drug · ANDA
Buprenorphine Hydrochloride NDC 0143-9246
Buprenorphine hydrochloride .324 mg/mL · Injection · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9246-05 | 0014392460500143924605 | 5 VIAL in 1 CARTON (0143-9246-05) / 1 mL in 1 VIAL (0143-9246-01)Marketed from Jul 12, 2019 |
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 Hydrochloride
- Generic name (nonproprietary)
- buprenorphine hydrochloride
- Active ingredients
- Buprenorphine hydrochloride — .324 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076931
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0143-9246_8ba9787c-d429-4a5d-8424-e13be15cb9f1SPL ID 8ba9787c-d429-4a5d-8424-e13be15cb9f1SPL set ID adc1167e-910e-4d7b-abdc-751d3df0c3dcRxCUI 238129UNII 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 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
N400143924605followed by a unit qualifier and the quantityPackage 00143-9246-05. 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 HCl 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, even at recommended doses [see WARNINGS: Addiction, Abuse, and Misuse ] reserve Buprenorphine HCl 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. Buprenorphine HCl Injection should not be used f…
Excerpt only. Read the full label for complete information.
About NDC 0143-9246
- What is NDC 0143-9246?
- 0143-9246 is the product NDC for Buprenorphine Hydrochloride, Buprenorphine hydrochloride .324 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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 |