NDC codes

FDA NDC Directory
Product NDC (as listed)52536-600Labeler and product segments. Claims need a package NDC.
Product NDC at billing width52536-0600Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
52536-600-11525360600111 BOTTLE in 1 CARTON (52536-600-11) / 120 mL in 1 BOTTLEMarketed from Apr 1, 2023
52536-600-12525360600121 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
Baclofen5 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

N452536060011 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 215602

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 215602
ProductStrengthForm · routeLabelerProduct NDC
FleqsuvybaclofenBaclofen 5 mg/mLSuspensionOralAzurity Pharmaceuticals, Inc.52652-6001

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