Prescription drug · ANDA
Metformin Hydrochloride NDC 62135-684
Metformin hydrochloride 1000 mg/1 · Tablet · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-684-05 | 62135068405 | 500 TABLET in 1 BOTTLE (62135-684-05)Marketed from Apr 6, 2022 | |
| 62135-684-10 | 62135068410 | 1000 TABLET in 1 BOTTLE (62135-684-10)Marketed from Apr 6, 2022 | |
| 62135-684-18 | 62135068418 | 180 TABLET in 1 BOTTLE (62135-684-18)Marketed from Apr 6, 2022 | |
| 62135-684-60 | 62135068460 | 60 TABLET in 1 BOTTLE (62135-684-60)Marketed from Apr 6, 2022 | |
| 62135-684-90 | 62135068490 | 90 TABLET in 1 BOTTLE (62135-684-90)Marketed from Apr 6, 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
- Generic name (nonproprietary)
- metformin hydrochloride
- Active ingredients
- Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075972
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 62135-684_570c5a61-a145-01f8-e063-6394a90acba5SPL ID 570c5a61-a145-01f8-e063-6394a90acba5SPL set ID 4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cdRxCUI 861004, 861007, 861010, 861021, 2703582UNII 786Z46389EUPC 0362135684051, 0362135681302, 0362135682309, 0362135680053, 0362135684907, 0362135683184, 0362135680183, 0362135680909, 0362135683306, 0362135684181, 0362135683900
- 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
N462135068405followed by a unit qualifier and the quantityPackage 62135-0684-05. 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)
Metformin hydrochloride tablets 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 tablets are 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.
Other NDCs under ANDA 075972
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 | Metformin hydrochloride 625 mg/1 | TabletOral | Lifsa Drugs, LLC | 72336-064 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | TabletOral | Lifsa Drugs, LLC | 72336-095 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Chartwell RX, LLC | 62135-680 |
| Metformin Hydrochloride | Metformin hydrochloride 625 mg/1 | TabletOral | Chartwell RX, LLC | 62135-681 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | TabletOral | Chartwell RX, LLC | 62135-682 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Chartwell RX, LLC | 62135-683 |