Prescription drug · ANDA
Metformin Hydrochloride Extended Release (Metformin hydrochloride) NDC 49483-623
Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · TIME CAP LABORATORIES, INC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)49483-623Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49483-0623Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49483-623-01 | 4948306230149483062301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-01)Marketed from Jun 28, 2016 | |
| 49483-623-09 | 4948306230949483062309 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-09)Marketed from Jun 5, 2017 | |
| 49483-623-10 | 4948306231049483062310 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-10)Marketed from Jun 5, 2017 | |
| 49483-623-50 | 4948306235049483062350 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-50)Marketed from Jun 28, 2016 |
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 Extended Release
- Generic name (nonproprietary)
- metformin hydrochloride
- Active ingredients
- Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- TIME CAP LABORATORIES, INCNDC labeler code 49483
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090295
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 49483-623_4d845f5a-3ab1-b5ac-e063-6394a90a75d6SPL ID 4d845f5a-3ab1-b5ac-e063-6394a90a75d6SPL set ID 1d8b8970-c2a1-4780-be87-ab8ccfd401faRxCUI 860975, 860981UNII 786Z46389EUPC 0349483624014, 0349483623109, 0349483623017
- 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
N449483062301followed by a unit qualifier and the quantityPackage 49483-0623-01. 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 Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablet is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1)
Excerpt only. Read the full label for complete information.
About NDC 49483-623
- What is NDC 49483-623?
- 49483-623 is the product NDC for Metformin Hydrochloride Extended Release, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by TIME CAP LABORATORIES, INC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metformin Hydrochloride Extended Release (Metformin Hydrochloride).
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- TIME CAP LABORATORIES, INC, NDC labeler code 49483. 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 Extended Release?
- 10 other product NDCs are listed under this name. See all Metformin Hydrochloride Extended Release 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 Extended Release 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 Extended Releasemetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-555 | 51655-0555-96 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | direct rx | 72189-064 | 72189-0064-3072189-0064-90 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-902 | 43063-0902-3043063-0902-60 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | TIME CAP LABORATORIES, INC | 49483-624 | 49483-0624-0149483-0624-50 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3111 | 68071-3111-0268071-3111-0368071-3111-06+2 more |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0293 | 71335-0293-0171335-0293-0271335-0293-03+6 more |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0889 | 71335-0889-0171335-0889-0271335-0889-03+2 more |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-454 | 71610-0454-3071610-0454-5371610-0454-60+4 more |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-009 | 72789-0009-3072789-0009-6072789-0009-90+1 more |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-148 | 82804-0148-0082804-0148-30 |
Other NDCs under ANDA 090295
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 500 mg/1 | Tablet, Extended releaseOral | MARKSANS PHARMA LIMITED | 25000-101 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | MARKSANS PHARMA LIMITED | 25000-102 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-902 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | TIME CAP LABORATORIES, INC | 49483-624 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-555 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3111 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0293 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0889 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-454 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | direct rx | 72189-064 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-009 |
| Metformin Hydrochloride Extended Releasemetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-148 |