Prescription drug · ANDA
Carbidopa and Levodopa NDC 0904-7549
Carbidopa hydrate 25 mg/1; Levodopa 250 mg/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7549-61 | 00904754961 | 100 BLISTER PACK in 1 CARTON (0904-7549-61) / 1 TABLET in 1 BLISTER PACKMarketed from Apr 28, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 25 mg/1Levodopa — 250 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073607
- Marketing start
- Listing expires
- Other FDA classes
- Aromatic (Chemical structure)
- Identifiers
- Product ID 0904-7549_1c723c43-1507-4e1a-b5f7-494f02587cf0SPL ID 1c723c43-1507-4e1a-b5f7-494f02587cf0SPL set ID 3f6d393e-ac84-4a3c-a837-199d1ec71fd2RxCUI 197444, 197445UNII 46627O600J, MNX7R8C5VO
- 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
N400904754961followed by a unit qualifier and the quantityPackage 00904-7549-61. 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 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. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on carbidopa and levodopa tablets. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbi…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 073607
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 250 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8516 |
| Carbidopa and Levodopa | Carbidopa 25 mg/1; Levodopa 250 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc | 75907-021 |
| Carbidopa and Levodopa | Carbidopa hydrate 25 mg/1; Levodopa 250 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0192 |