Prescription drug · ANDA
Methadone Hydrochloride NDC 66689-695
Methadone hydrochloride 10 mg/mL · Concentrate · Oral · VistaPharm, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 66689-695-79 | 6668906957966689069579 | 1000 mL in 1 BOTTLE (66689-695-79)Marketed from Mar 29, 2017 |
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)
- Methadone Hydrochloride
- Generic name (nonproprietary)
- methadone hydrochloride
- Active ingredients
- Methadone hydrochloride — 10 mg/mL
- Dosage form
- Concentrate
- Route
- Oral
- Labeler
- VistaPharm, LLCNDC labeler code 66689
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040088
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 66689-695_a139d04a-25e0-499f-8bfb-43328f560410SPL ID a139d04a-25e0-499f-8bfb-43328f560410SPL set ID d5bd3e97-b3f6-4bc2-9fb7-02921be35cdbRxCUI 991147UNII 229809935B
- Pharmacologic class
- 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. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N466689069579followed by a unit qualifier and the quantityPackage 66689-0695-79. 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)
Methadone hydrochloride oral concentrate contains methadone, an opioid agonist indicated for the: detoxification treatment of opioid addiction (heroin or other morphine-like drugs). maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of Use Methadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8 [see Dosage and Administration ( 2.1 )] . Methadone hydrochloride oral concentrate is an opioid agonist indicated for the: Detoxification treatment of opioid a…
Excerpt only. Read the full label for complete information.
About NDC 66689-695
- What is NDC 66689-695?
- 66689-695 is the product NDC for Methadone Hydrochloride, Methadone hydrochloride 10 mg/mL concentrate, listed with the FDA by VistaPharm, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methadone Hydrochloride.
- What is the active ingredient?
- Methadone hydrochloride.
- Who is the labeler?
- VistaPharm, LLC, NDC labeler code 66689. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Methadone Hydrochloride?
- 41 other product NDCs are listed under this name. See all Methadone Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methadone 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) |
|---|---|---|---|---|---|
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/1 | TabletOral | American Health Packaging | 60687-910 | 60687-0910-01 |
| Methadone Hydrochloride | Methadone hydrochloride 5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-659 | 67877-0659-01 |
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-660 | 67877-0660-01 |
| Methadone Hydrochloride | Methadone hydrochloride 200 mg/20mL | InjectionIntravenous | Long Grove Pharmaceuticals, LLC | 81298-7500 | 81298-7500-01 |
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/mL | InjectionIntramuscular, Intravenous, Subcutaneous | Hikma Pharmaceuticals USA Inc. | 0641-6266 | 00641-6266-01 |
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Breckenridge Pharmaceutical Inc | 51991-002 | 51991-0002-98 |
| Methadone Hydrochloride | Methadone hydrochloride 5 mg/5mL | SolutionOral | American Health Packaging | 60687-818 | 60687-0818-86 |
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7417 | 00904-7417-61 |
| Methadone Hydrochloride | Methadone hydrochloride 5 mg/5mL | SolutionOral | Precision Dose, Inc. | 68094-331 | 68094-0331-58 |
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/mL | ConcentrateOral | SpecGx LLC | 0406-4123 | 00406-4123-0300406-4123-10 |
Other NDCs under ANDA 040088
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 |
|---|---|---|---|---|
| Methadone Hydrochloride | Methadone hydrochloride 10 mg/mL | ConcentrateOral | VistaPharm, LLC | 66689-694 |