Prescription drug · ANDA
Metformin Hydrochloride NDC 71335-1834
Metformin hydrochloride 500 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC DirectoryProduct NDC (as listed)71335-1834Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1834Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1834-0 | 7133518340071335183400 | 25 TABLET in 1 BOTTLE (71335-1834-0)Marketed from Apr 29, 2021 | |
| 71335-1834-1 | 7133518340171335183401 | 30 TABLET in 1 BOTTLE (71335-1834-1)Marketed from Apr 29, 2021 | |
| 71335-1834-2 | 7133518340271335183402 | 60 TABLET in 1 BOTTLE (71335-1834-2)Marketed from Apr 29, 2021 | |
| 71335-1834-3 | 7133518340371335183403 | 100 TABLET in 1 BOTTLE (71335-1834-3)Marketed from Apr 29, 2021 | |
| 71335-1834-4 | 7133518340471335183404 | 120 TABLET in 1 BOTTLE (71335-1834-4)Marketed from Apr 29, 2021 | |
| 71335-1834-5 | 7133518340571335183405 | 90 TABLET in 1 BOTTLE (71335-1834-5)Marketed from Apr 29, 2021 | |
| 71335-1834-6 | 7133518340671335183406 | 28 TABLET in 1 BOTTLE (71335-1834-6)Marketed from Apr 29, 2021 | |
| 71335-1834-7 | 7133518340771335183407 | 56 TABLET in 1 BOTTLE (71335-1834-7)Marketed from Apr 29, 2021 | |
| 71335-1834-8 | 7133518340871335183408 | 180 TABLET in 1 BOTTLE (71335-1834-8)Marketed from Apr 29, 2021 | |
| 71335-1834-9 | 7133518340971335183409 | 10 TABLET in 1 BOTTLE (71335-1834-9)Marketed from Apr 29, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203769
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 71335-1834_23510474-e95a-4ce5-8ff4-a445e34ce83aSPL ID 23510474-e95a-4ce5-8ff4-a445e34ce83aSPL set ID 32d6c5f4-0116-4e38-b179-e1967ae63e66RxCUI 861007UNII 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
N471335183400followed by a unit qualifier and the quantityPackage 71335-1834-00. 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 are 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 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 71335-1834
- What is NDC 71335-1834?
- 71335-1834 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metformin Hydrochloride.
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 71335. 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?
- 366 other product NDCs are listed under this name. See all Metformin Hydrochloride 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 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 | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4781 | 70518-4781-00 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Marlex Pharmaceuticals, Inc. | 10135-823 | 10135-0823-0510135-0823-1010135-0823-30+5 more |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Marlex Pharmaceuticals, Inc. | 10135-824 | 10135-0824-0510135-0824-1010135-0824-90 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4185 | 68788-4185-0168788-4185-0368788-4185-06+3 more |
| Metformin Hydrochloride | Metformin hydrochloride 625 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-588 | 50228-0588-0550228-0588-30 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-589 | 50228-0589-0550228-0589-30 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4710 | 70518-4710-0070518-4710-02 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4698 | 70518-4698-00 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0591 | 80425-0591-0180425-0591-0280425-0591-03+1 more |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-054 | 87441-0054-01 |
Other NDCs under ANDA 203769
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 | TabletOral | Preferred Pharmaceuticals Inc | 68788-4076 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-180 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-181 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Westminster Pharmaceuticals, LLC | 69367-182 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | A-S Medication Solutions | 50090-7588 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | A-S Medication Solutions | 50090-7586 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | A-S Medication Solutions | 50090-7587 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1522 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | direct rx | 72189-219 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1523 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | direct rx | 72189-220 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | direct rx | 72189-221 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-672 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-917 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-918 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-923 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-783 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-784 |
| Metformin Hydrochloride | Metformin hydrochloride 625 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-588 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-589 |
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