Prescription drug · ANDA
Methadone Hydrocloride dye-free, sugar-free, unflavored (Methadone hydrochloride) NDC 0527-1927
Methadone hydrochloride 10 mg/mL · Concentrate · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-1927-36 | 0052719273600527192736 | 1 BOTTLE, PLASTIC in 1 CARTON (0527-1927-36) / 30 mL in 1 BOTTLE, PLASTICMarketed from Nov 2, 2020 | |
| 0527-1927-39 | 0052719273900527192739 | 1000 mL in 1 BOTTLE, PLASTIC (0527-1927-39)Marketed from Nov 2, 2020 |
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)
- Methadone Hydrocloride dye-free, sugar-free, unflavoredSuffix: dye-free, sugar-free, unflavored
- Generic name (nonproprietary)
- methadone hydrochloride
- Active ingredients
- Methadone hydrochloride — 10 mg/mL
- Dosage form
- Concentrate
- Route
- Oral
- Labeler
- Lannett Company, Inc.NDC labeler code 0527
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212093
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0527-1927_127a6533-e403-48b1-9592-5a90d5cf155eSPL ID 127a6533-e403-48b1-9592-5a90d5cf155eSPL set ID 0955ea4a-c6b8-431f-ba42-9641b5b102eaRxCUI 991147UNII 229809935BUPC 0305271927361
- 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
N400527192736followed by a unit qualifier and the quantityPackage 00527-1927-36. 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 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 is an opioid agonist indicated for the: Detoxification treatment of opioid addiction (heroin or other morphine…
Excerpt only. Read the full label for complete information.
About NDC 0527-1927
- What is NDC 0527-1927?
- 0527-1927 is the product NDC for Methadone Hydrocloride dye-free, sugar-free, unflavored, Methadone hydrochloride 10 mg/mL concentrate, listed with the FDA by Lannett Company, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Methadone Hydrocloride dye-free, sugar-free, unflavored (Methadone hydrochloride).
- What is the active ingredient?
- Methadone hydrochloride.
- Who is the labeler?
- Lannett Company, Inc., NDC labeler code 0527. 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 Hydrocloride dye-free, sugar-free, unflavored?
- 3 other product NDCs are listed under this name. See all Methadone Hydrocloride dye-free, sugar-free, unflavored NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Methadone Hydrocloride dye-free, sugar-free, unflavored 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 Hydrocloride dye-free, sugar-free, unflavoredmethadone hydrochloride | Methadone hydrochloride 10 mg/mL | ConcentrateOral | Atlantic Biologicals Corp. | 17856-1927 | 17856-1927-0717856-1927-0817856-1927-09 |
| Methadone Hydrocloride dye-free, sugar-free, unflavoredmethadone hydrochloride | Methadone hydrochloride 10 mg/mL | ConcentrateOral | Bryant Ranch Prepack | 63629-2098 | 63629-2098-01 |
| Methadone Hydrocloride dye-free, sugar-free, unflavoredmethadone hydrochloride | Methadone hydrochloride 10 mg/mL | ConcentrateOral | Bryant Ranch Prepack | 72162-1085 | 72162-1085-02 |
Other NDCs under ANDA 212093
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 Hydrocloride dye-free, sugar-free, unflavoredmethadone hydrochloride | Methadone hydrochloride 10 mg/mL | ConcentrateOral | Atlantic Biologicals Corp. | 17856-1927 |
| Methadone Hydrocloride dye-free, sugar-free, unflavoredmethadone hydrochloride | Methadone hydrochloride 10 mg/mL | ConcentrateOral | Bryant Ranch Prepack | 63629-2098 |
| Methadone Hydrocloride dye-free, sugar-free, unflavoredmethadone hydrochloride | Methadone hydrochloride 10 mg/mL | ConcentrateOral | Bryant Ranch Prepack | 72162-1085 |