Prescription drug · ANDA
buprenorphine hydrochloride and naloxone hydrochloride dihydrate NDC 70518-3844
Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 · Tablet · Sublingual · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3844-0 | 70518384400 | 30 TABLET in 1 BLISTER PACK (70518-3844-0)Marketed from Aug 29, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 and naloxone hydrochloride dihydrate
- Generic name (nonproprietary)
- buprenorphine hydrochloride and naloxone hydrochloride dihydrate
- Active ingredients
- Buprenorphine hydrochloride — 8 mg/1Naloxone hydrochloride dihydrate — 2 mg/1
- Dosage form
- Tablet
- Route
- Sublingual
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203326
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
- Identifiers
- Product ID 70518-3844_594245b3-4016-e5d8-e063-6294a90ae6a2SPL ID 594245b3-4016-e5d8-e063-6294a90ae6a2SPL set ID 4124c4ad-ef62-4c95-8e57-0d843862ae71RxCUI 351267UNII 56W8MW3EN1, 5Q187997EE
- Pharmacologic class
- Opioid Antagonist; 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
N470518384400followed by a unit qualifier and the quantityPackage 70518-3844-00. 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 and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine and Naloxone Sublingual Tablets contain buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist, and are indicated for the maintenance treatment of opioid dependence. ( 1 ) Buprenorphine and Naloxone 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.
Other NDCs under ANDA 203326
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Major Pharmaceuticals | 0904-7009 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Major Pharmaceuticals | 0904-7010 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | REMEDYREPACK INC. | 70518-3862 |
| buprenorphine and naloxone | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Hikma Pharmaceuticals USA Inc. | 0054-0188 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Clinical Solutions Wholesale, LLC | 58118-1188 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Clinical Solutions Wholesale, LLC | 58118-1189 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-1653 |
| buprenorphine and naloxone | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Hikma Pharmaceuticals USA Inc. | 0054-0189 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 2 mg/1; Naloxone hydrochloride dihydrate .5 mg/1 | TabletSublingual | Bryant Ranch Prepack | 71335-1720 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Naloxone hydrochloride dihydrate .5 mg/1; Buprenorphine hydrochloride 2 mg/1 | TabletSublingual | Golden State Medical Supply, Inc. | 51407-948 |
| buprenorphine hydrochloride and naloxone hydrochloride dihydrate | Buprenorphine hydrochloride 8 mg/1; Naloxone hydrochloride dihydrate 2 mg/1 | TabletSublingual | Golden State Medical Supply, Inc. | 51407-949 |