Prescription drug · ANDA
Carbidopa and Levodopa NDC 48433-016
Carbidopa hydrate 50 mg/1; Levodopa 200 mg/1 · Tablet, Extended release · Oral · Safecor Health, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 48433-016-20 | 4843300162048433001620 | 100 BLISTER PACK in 1 CARTON (48433-016-20) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (48433-016-01)Marketed from Mar 13, 2026 |
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)
- Carbidopa and Levodopa
- Generic name (nonproprietary)
- carbidopa and levodopa
- Active ingredients
- Carbidopa hydrate — 50 mg/1Levodopa — 200 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Safecor Health, LLCNDC labeler code 48433
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075091
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 48433-016_4d642d35-3931-745e-e063-6294a90a8e63SPL ID 4d642d35-3931-745e-e063-6294a90a8e63SPL set ID 015bc056-ee86-4006-ae7c-689b95e566f4RxCUI 308988, 308989UNII MNX7R8C5VO, 46627O600J
- Pharmacologic class
- Aromatic Amino Acid
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
N448433001620followed by a unit qualifier and the quantityPackage 48433-0016-20. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.
Excerpt only. Read the full label for complete information.
About NDC 48433-016
- What is NDC 48433-016?
- 48433-016 is the product NDC for Carbidopa and Levodopa, Carbidopa hydrate 50 mg/1; Levodopa 200 mg/1 tablet, extended release, listed with the FDA by Safecor Health, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carbidopa and Levodopa.
- What is the active ingredient?
- Carbidopa hydrate, Levodopa.
- Who is the labeler?
- Safecor Health, LLC, NDC labeler code 48433. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Carbidopa and Levodopa?
- 97 other product NDCs are listed under this name. See all Carbidopa and Levodopa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Carbidopa and Levodopa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | Coupler LLC | 67046-1689 | 67046-1689-03 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | AvPAK | 50268-202 | 50268-0202-15 |
| Carbidopa and Levodopa | Carbidopa 48.75 mg/1; Levodopa 195 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4621 | 70518-4621-00 |
| Carbidopa and Levodopa | Carbidopa 23.75 mg/1; Levodopa 95 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4618 | 70518-4618-00 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4620 | 70518-4620-00 |
| Carbidopa and Levodopa | Carbidopa 36.25 mg/1; Levodopa 145 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4630 | 70518-4630-00 |
| Carbidopa and Levodopa | Carbidopa 61.25 mg/1; Levodopa 245 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4610 | 70518-4610-00 |
| Carbidopa And Levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | Coupler LLC | 67046-1668 | 67046-1668-03 |
| Carbidopa and Levodopa | Carbidopa hydrate 25 mg/1; Levodopa 100 mg/1 | Tablet, Extended releaseOral | Safecor Health, LLC | 48433-015 | 48433-0015-20 |
| Carbidopa And Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-020 | 53401-0020-6053401-0020-80 |
Other NDCs under ANDA 075091
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 |
|---|---|---|---|---|
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | Tablet, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-0088 |
| Carbidopa and Levodopa | Carbidopa 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | Mylan Pharmaceuticals Inc. | 0378-0094 |
| Carbidopa and Levodopa | Carbidopa hydrate 25 mg/1; Levodopa 100 mg/1 | Tablet, Extended releaseOral | Safecor Health, LLC | 48433-015 |
| Carbidopa and Levodopa | Carbidopa 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | Mylan Institutional Inc. | 51079-923 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | Tablet, Extended releaseOral | Mylan Institutional Inc. | 51079-978 |