Prescription drug · ANDA
Metformin Hydrochloride Oral Solution (Metformin hydrochloride) NDC 52817-820
Metformin hydrochloride 500 mg/5mL · Solution · Oral · TRUPHARMA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-820-50 | 5281708205052817082050 | 5 TRAY in 1 CASE (52817-820-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSEMarketed from Jan 25, 2022 |
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)
- Metformin Hydrochloride Oral Solution
- Generic name (nonproprietary)
- metformin hydrochloride
- Active ingredients
- Metformin hydrochloride — 500 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- TRUPHARMA, LLCNDC labeler code 52817
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211309
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 52817-820_2a4320c6-8080-9ddc-e063-6294a90aa921SPL ID 2a4320c6-8080-9ddc-e063-6294a90aa921SPL set ID 73691c6c-8841-4c5d-b4a5-c3ed3b5effa1RxCUI 861025UNII 786Z46389E
- Pharmacologic class
- Biguanide
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
N452817082050followed by a unit qualifier and the quantityPackage 52817-0820-50. 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)
Metformin hydrochloride oral solution is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 52817-820
- What is NDC 52817-820?
- 52817-820 is the product NDC for Metformin Hydrochloride Oral Solution, Metformin hydrochloride 500 mg/5mL solution, listed with the FDA by TRUPHARMA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metformin Hydrochloride Oral Solution (Metformin Hydrochloride).
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- TRUPHARMA, LLC, NDC labeler code 52817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Metformin Hydrochloride Oral Solution?
- 4 other product NDCs are listed under this name. See all Metformin Hydrochloride Oral Solution NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metformin Hydrochloride Oral Solution products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metformin Hydrochloride Oral Solutionmetformin hydrochloride | Metformin hydrochloride 500 mg/5mL | SolutionOral | Bionpharma Inc., | 69452-380 | 69452-0380-5569452-0380-88 |
| Metformin Hydrochloride Oral Solutionmetformin hydrochloride | Metformin hydrochloride 500 mg/5mL | SolutionOral | Saptalis Pharmaceuticals, LLC. | 71656-017 | 71656-0017-04 |
| Metformin Hydrochloride Oral Solutionmetformin hydrochloride | Metformin hydrochloride 500 mg/5mL | SolutionOral | TRUPHARMA, LLC | 52817-821 | 52817-0821-50 |
| Metformin Hydrochloride Oral Solutionmetformin hydrochloride | Metformin hydrochloride 500 mg/5mL | SolutionOral | MICRO LABS LIMITED | 42571-360 | 42571-0360-0742571-0360-10 |
Other NDCs under ANDA 211309
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 |
|---|---|---|---|---|
| Metformin Hydrochloride Oral Solutionmetformin hydrochloride | Metformin hydrochloride 500 mg/5mL | SolutionOral | MICRO LABS LIMITED | 42571-360 |
| Metformin Hydrochloride Oral Solutionmetformin hydrochloride | Metformin hydrochloride 500 mg/5mL | SolutionOral | TRUPHARMA, LLC | 52817-821 |
| Metformin Hydrochloride Oral Solutionmetformin hydrochloride | Metformin hydrochloride 500 mg/5mL | SolutionOral | Saptalis Pharmaceuticals, LLC. | 71656-017 |