What is NDC 71335-9638?

71335-9638 is the product NDC for Baclofen, Baclofen 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-9638 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-9638Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-9638Add 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
71335-9638-0	7133596380071335963800	112 TABLET in 1 BOTTLE (71335-9638-0)Marketed from May 30, 2024
71335-9638-1	7133596380171335963801	30 TABLET in 1 BOTTLE (71335-9638-1)Marketed from Mar 16, 2023
71335-9638-2	7133596380271335963802	120 TABLET in 1 BOTTLE (71335-9638-2)Marketed from May 24, 2023
71335-9638-3	7133596380371335963803	20 TABLET in 1 BOTTLE (71335-9638-3)Marketed from Dec 21, 2023
71335-9638-4	7133596380471335963804	60 TABLET in 1 BOTTLE (71335-9638-4)Marketed from Mar 24, 2023
71335-9638-5	7133596380571335963805	100 TABLET in 1 BOTTLE (71335-9638-5)Marketed from May 30, 2024
71335-9638-6	7133596380671335963806	56 TABLET in 1 BOTTLE (71335-9638-6)Marketed from May 30, 2024
71335-9638-7	7133596380771335963807	90 TABLET in 1 BOTTLE (71335-9638-7)Marketed from Apr 3, 2023
71335-9638-8	7133596380871335963808	140 TABLET in 1 BOTTLE (71335-9638-8)Marketed from May 30, 2024
71335-9638-9	7133596380971335963809	84 TABLET in 1 BOTTLE (71335-9638-9)Marketed from May 30, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209102
Marketing start: Apr 1, 2018
Listing expires: Dec 31, 2026
Other FDA classes: GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
Identifiers: Product ID 71335-9638_1223f677-9ada-40f3-8eb2-aa61fe18d50aSPL ID 1223f677-9ada-40f3-8eb2-aa61fe18d50aSPL set ID 9834e409-8633-4f99-8ac7-7fa298d01c44RxCUI 197391UNII 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

N471335963800 followed by a unit qualifier and the quantity

Package 71335-9638-00. 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 May 30, 2024.

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, the…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-9638

What is NDC 71335-9638?: 71335-9638 is the product NDC for Baclofen, Baclofen 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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 209102

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

FDA NDC Directory listings under ANDA 209102
Product	Strength	Form · route	Labeler	Product NDC
Baclofen	Baclofen 5 mg/1	TabletOral	Major Pharmaceuticals	0904-7558
Baclofen	Baclofen 20 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0157
Baclofen	Baclofen 20 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-480
Baclofen	Baclofen 5 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-478
Baclofen	Baclofen 10 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-479
Baclofen	Baclofen 15 mg/1	TabletOral	Advagen Pharma Limited	72888-202
Baclofen	Baclofen 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4290
Baclofen	Baclofen 20 mg/1	TabletOral	Bryant Ranch Prepack	71335-0949
Baclofen	Baclofen 20 mg/1	TabletOral	REMEDYREPACK INC.	70518-4530
Baclofen	Baclofen 10 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-508
Baclofen	Baclofen 10 mg/1	TabletOral	Asclemed USA, Inc.	76420-357
Baclofen	Baclofen 5 mg/1	TabletOral	Asclemed USA, Inc.	76420-356
Baclofen	Baclofen 15 mg/1	TabletOral	Asclemed USA, Inc.	76420-358
Baclofen	Baclofen 20 mg/1	TabletOral	Asclemed USA, Inc.	76420-359
Baclofen	Baclofen 20 mg/1	TabletOral	TruPharma LLC	52817-321
Baclofen	Baclofen 15 mg/1	TabletOral	TruPharma LLC	52817-318
Baclofen	Baclofen 5 mg/1	TabletOral	TruPharma LLC	52817-319
Baclofen	Baclofen 10 mg/1	TabletOral	TruPharma LLC	52817-320
Baclofen	Baclofen 10 mg/1	TabletOral	SOLA Pharmaceuticals, LLC	70512-782
Baclofen	Baclofen 20 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-312

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