Prescription drug · ANDA
Carbidopa and Levodopa NDC 46708-332
Carbidopa 25 mg/1; Levodopa 100 mg/1 · Tablet, Extended release · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-332-30 | 4670803323046708033230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-332-30)Marketed from Jun 6, 2019 | |
| 46708-332-31 | 4670803323146708033231 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-332-31)Marketed from Jun 6, 2019 | |
| 46708-332-91 | 4670803329146708033291 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-332-91)Marketed from Jun 6, 2019 |
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
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210341
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 46708-332_a85a56c5-44dd-41d4-ac1c-bdc4758406a4SPL ID a85a56c5-44dd-41d4-ac1c-bdc4758406a4SPL set ID a85a56c5-44dd-41d4-ac1c-bdc4758406a4RxCUI 308988, 308989UNII MNX7R8C5VO, 46627O600JUPC 0346708332303, 0346708333300
- 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
N446708033230followed by a unit qualifier and the quantityPackage 46708-0332-30. 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, USP 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 46708-332
- What is NDC 46708-332?
- 46708-332 is the product NDC for Carbidopa and Levodopa, Carbidopa 25 mg/1; Levodopa 100 mg/1 tablet, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carbidopa and Levodopa.
- What is the active ingredient?
- Carbidopa, Levodopa.
- Who is the labeler?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 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 48.75 mg/1; Levodopa 195 mg/1 | Capsule, Extended releaseOral | REMEDYREPACK INC. | 70518-4621 | 70518-4621-00 |
| 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 hydrate 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | Safecor Health, LLC | 48433-016 | 48433-0016-20 |
Other NDCs under ANDA 210341
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 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Limited | 46708-333 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-332 |
| Carbidopa and Levodopa | Carbidopa 50 mg/1; Levodopa 200 mg/1 | Tablet, Extended releaseOral | Alembic Pharmaceuticals Inc. | 62332-333 |