What is NDC 0527-1337?

0527-1337 is the product NDC for Baclofen, Baclofen 20 mg/1 tablet, listed with the FDA by Lannett Company, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Lannett Company, Inc., NDC labeler code 0527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Baclofen?

219 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Baclofen NDC 0527-1337 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-1337Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-1337Add 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 NDC	11-digit (billing)	Package
0527-1337-01	0052713370100527133701	100 TABLET in 1 BOTTLE, PLASTIC (0527-1337-01)Marketed from Dec 20, 2005
0527-1337-05	0052713370500527133705	500 TABLET in 1 BOTTLE, PLASTIC (0527-1337-05)Marketed from Dec 20, 2005
0527-1337-10	0052713371000527133710	1000 TABLET in 1 BOTTLE, PLASTIC (0527-1337-10)Marketed from Dec 20, 2005

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): Baclofen
Generic name (nonproprietary): baclofen
Active ingredients: Baclofen — 20 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lannett Company, Inc.NDC labeler code 0527
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077241
Marketing start: Dec 20, 2005
Listing expires: Dec 31, 2027
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 0527-1337_153f6bd7-9462-4d92-b738-48e7807c5919SPL ID 153f6bd7-9462-4d92-b738-48e7807c5919SPL set ID f84f3f4c-17e6-43f1-9600-63b0b175837bRxCUI 197391, 197392, 430902UNII H789N3FKE8UPC 0305271333018
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

N400527133701 followed by a unit qualifier and the quantity

Package 00527-1337-01. 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 Feb 24, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, theref…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0527-1337

What is NDC 0527-1337?: 0527-1337 is the product NDC for Baclofen, Baclofen 20 mg/1 tablet, listed with the FDA by Lannett Company, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Baclofen.
What is the active ingredient?: Baclofen.
Who is the labeler?: Lannett Company, Inc., NDC labeler code 0527. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Baclofen?: 219 other product NDCs are listed under this name. See all Baclofen NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Baclofen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Baclofen	Baclofen 10 mg/5mL	SolutionOral	Acella Pharmaceuticals, LLC	42192-631	42192-0631-4042192-0631-45
Baclofen	Baclofen 20 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4162	68788-4162-0168788-4162-0368788-4162-06+2 more
Baclofen	Baclofen 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4656	70518-4656-00
Baclofen	Baclofen 10 mg/1	TabletOral	Coupler LLC	67046-1072	67046-1072-03
Baclofen	Baclofen 20 mg/1	TabletOral	Medcore LLC	82461-718	82461-0718-10
Baclofen	Baclofen 10 mg/1	TabletOral	Medcore LLC	82461-717	82461-0717-10
Baclofen	Baclofen 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-0198	55154-0198-00
Baclofen	Baclofen 10 mg/1	TabletOral	Advanced Rx of Tennessee, LLC	80425-0568	80425-0568-0180425-0568-0280425-0568-03+1 more
Baclofen	Baclofen 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4530	70518-4530-0070518-4530-01
Baclofen	Baclofen 5 mg/1	TabletOral	Aurobindo Pharma Limited	84386-035	84386-0035-01

All 220 Baclofen NDCs

Other NDCs under ANDA 077241

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

FDA NDC Directory listings under ANDA 077241
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 20 mg/1	TabletOral	Cardinal Health 107, LLC	55154-7876
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	72162-1080
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-0103
Baclofen	Baclofen 5 mg/1	TabletOral	Chartwell RX, LLC	62135-472
Baclofen	Baclofen 10 mg/1	TabletOral	Chartwell RX, LLC	62135-473
Baclofen	Baclofen 20 mg/1	TabletOral	Chartwell RX, LLC	62135-474
Baclofen	Baclofen 10 mg/1	TabletOral	Marlex Pharmaceuticals Inc	10135-532
Baclofen	Baclofen 20 mg/1	TabletOral	Proficient Rx LP	63187-280
Baclofen	Baclofen 20 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-444
Baclofen	Baclofen 20 mg/1	TabletOral	Marlex Pharmaceuticals Inc	10135-533
Baclofen	Baclofen 10 mg/1	TabletOral	Proficient Rx LP	63187-313
Baclofen	Baclofen 20 mg/1	TabletOral	Major Pharmaceuticals	0904-6476
Baclofen	Baclofen 5 mg/1	TabletOral	Lannett Company, Inc.	0527-1333
Baclofen	Baclofen 20 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-865
Baclofen	Baclofen 20 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0112
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	63629-2084
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	63629-2083