What is NDC 0115-4422?

0115-4422 is the product NDC for Dantrolene Sodium, Dantrolene sodium 50 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dantrolene Sodium?

20 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dantrolene Sodium NDC 0115-4422 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0115-4422Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00115-4422Add 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
0115-4422-01	0011544220100115442201	100 CAPSULE in 1 BOTTLE (0115-4422-01)Marketed from Mar 1, 2005
0115-4422-02	0011544220200115442202	500 CAPSULE in 1 BOTTLE (0115-4422-02)Marketed from Mar 1, 2005
0115-4422-03	0011544220300115442203	1000 CAPSULE in 1 BOTTLE (0115-4422-03)Marketed from Mar 1, 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): Dantrolene Sodium
Generic name (nonproprietary): dantrolene sodium
Active ingredients: Dantrolene sodium — 50 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076856
Marketing start: Mar 1, 2005
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Striated Muscle Contraction (Physiologic effect)Decreased Striated Muscle Tone (Physiologic effect)
Identifiers: Product ID 0115-4422_c254d463-2f1c-4c34-9db0-917a7bac870fSPL ID c254d463-2f1c-4c34-9db0-917a7bac870fSPL set ID c3c45b27-f786-456e-95d6-2e38ef36190aRxCUI 856652, 856656, 856660UNII 287M0347EVUPC 0301154411019
Pharmacologic class: Skeletal Muscle Relaxant

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

N400115442201 followed by a unit qualifier and the quantity

Package 00115-4422-01. 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 May 12, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE In Chronic Spasticity Dantrolene sodium capsules are indicated in controlling the manifestations of clinical spasticity resulting from upper motor neuron disorders (e.g., spinal cord injury, stroke, cerebral palsy, or multiple sclerosis). It is of particular benefit to the patient whose functional rehabilitation has been retarded by the sequelae of spasticity. Such patients must have presumably reversible spasticity where relief of spasticity will aid in restoring residual function. Dantrolene sodium capsules are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. If improvement occurs, it will ordinarily occur within the dosage t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0115-4422

What is NDC 0115-4422?: 0115-4422 is the product NDC for Dantrolene Sodium, Dantrolene sodium 50 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dantrolene Sodium.
What is the active ingredient?: Dantrolene sodium.
Who is the labeler?: Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dantrolene Sodium?: 20 other product NDCs are listed under this name. See all Dantrolene Sodium 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 Dantrolene Sodium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
dantrolene sodium	Dantrolene sodium 50 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4668	70518-4668-00
dantrolene sodium	Dantrolene sodium 100 mg/1	CapsuleOral	REMEDYREPACK INC.	70518-4622	70518-4622-0070518-4622-02
Dantrolene Sodium	Dantrolene sodium 25 mg/1	CapsuleOral	AvPAK	50268-217	50268-0217-15
dantrolene sodium	Dantrolene sodium 25 mg/1	CapsuleOral	Par Health USA, LLC	49884-362	49884-0362-01
dantrolene sodium	Dantrolene sodium 50 mg/1	CapsuleOral	Par Health USA, LLC	49884-363	49884-0363-01
dantrolene sodium	Dantrolene sodium 100 mg/1	CapsuleOral	Par Health USA, LLC	49884-364	49884-0364-01
dantrolene sodium	Dantrolene sodium 25 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-2168	63629-2168-01
dantrolene sodium	Dantrolene sodium 50 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-2169	63629-2169-01
dantrolene sodium	Dantrolene sodium 25 mg/1	CapsuleOral	Bryant Ranch Prepack	72162-1497	72162-1497-01
Dantrolene Sodium	Dantrolene sodium 25 mg/1	CapsuleOral	American Health Packaging	68084-300	68084-0300-21

All 21 Dantrolene Sodium NDCs

Other NDCs under ANDA 076856

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

FDA NDC Directory listings under ANDA 076856
Product	Strength	Form · route	Labeler	Product NDC
Dantrolene Sodium	Dantrolene sodium 25 mg/1	CapsuleOral	Amneal Pharmaceuticals of New York LLC	0115-4411
Dantrolene Sodium	Dantrolene sodium 100 mg/1	CapsuleOral	Amneal Pharmaceuticals of New York LLC	0115-4433
Dantrolene Sodium	Dantrolene sodium 25 mg/1	CapsuleOral	Major Pharmaceuticals	0904-7211
Dantrolene Sodium	Dantrolene sodium 25 mg/1	CapsuleOral	AvPAK	50268-217
Dantrolene Sodium	Dantrolene sodium 25 mg/1	CapsuleOral	Cardinal Health 107, LLC	55154-7140
Dantrolene Sodium	Dantrolene sodium 25 mg/1	CapsuleOral	American Health Packaging	68084-300