Prescription drug · NDA AUTHORIZED GENERIC
Baclofen NDC 52536-600
Baclofen 5 mg/mL · Suspension · Oral · Wilshire Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52536-600-11 | 52536060011 | 1 BOTTLE in 1 CARTON (52536-600-11) / 120 mL in 1 BOTTLEMarketed from Apr 1, 2023 | |
| 52536-600-12 | 52536060012 | 1 BOTTLE in 1 CARTON (52536-600-12) / 300 mL in 1 BOTTLEMarketed from Apr 1, 2023 |
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)
- Baclofen
- Generic name (nonproprietary)
- baclofen
- Active ingredients
- Baclofen — 5 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 215602
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 52536-600_461e14b2-890c-011c-e063-6294a90a0d4cSPL ID 461e14b2-890c-011c-e063-6294a90a0d4cSPL set ID 4585aafe-0af8-4786-a419-6a7e76671ca2RxCUI 2593376UNII H789N3FKE8
- Pharmacologic class
- gamma-Aminobutyric Acid-ergic Agonist
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
N452536060011followed by a unit qualifier and the quantityPackage 52536-0600-11. 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)
Baclofen is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. Baclofen is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. ( 1 ) Baclofen may also be of some value in patient…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 215602
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 |
|---|---|---|---|---|
| Fleqsuvybaclofen | Baclofen 5 mg/mL | SuspensionOral | Azurity Pharmaceuticals, Inc. | 52652-6001 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.