What is NDC 64380-166?

64380-166 is the product NDC for Phenobarbital, Phenobarbital 20 mg/5mL elixir, listed with the FDA by Strides Pharma Science Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Strides Pharma Science Limited, NDC labeler code 64380. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Phenobarbital?

152 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Phenobarbital NDC 64380-166 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64380-166Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64380-0166Add 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	Copy
64380-166-01	6438001660164380016601	473 mL in 1 BOTTLE, PLASTIC (64380-166-01)Marketed from Apr 4, 2022

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): Phenobarbital
Generic name (nonproprietary): phenobarbital
Active ingredients: Phenobarbital — 20 mg/5mL
Dosage form: Elixir
Route: Oral
Labeler: Strides Pharma Science LimitedNDC labeler code 64380
Product type: Prescription drug
Marketing category: Unapproved drug (other)
Marketing start: Apr 4, 2022
Listing expires: Dec 31, 2027
DEA schedule: CIV
Identifiers: Product ID 64380-166_fac9083b-0b86-4d8d-b843-25f74f217e15SPL ID fac9083b-0b86-4d8d-b843-25f74f217e15SPL set ID b3ed0ef0-41de-46b1-af5f-4b940e74921bRxCUI 702519UNII YQE403BP4DUPC 0364380166016

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

N464380016601 followed by a unit qualifier and the quantity

Package 64380-0166-01. 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 Apr 6, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE A. Sedative B. Anticonvulsant–For the treatment of generalized and partial seizures.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64380-166

What is NDC 64380-166?: 64380-166 is the product NDC for Phenobarbital, Phenobarbital 20 mg/5mL elixir, listed with the FDA by Strides Pharma Science Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Phenobarbital.
What is the active ingredient?: Phenobarbital.
Who is the labeler?: Strides Pharma Science Limited, NDC labeler code 64380. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Phenobarbital?: 152 other product NDCs are listed under this name. See all Phenobarbital 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 Phenobarbital NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Phenobarbital	Phenobarbital 64.8 mg/1	TabletOral	Chartwell RX, LLC	62135-557	62135-0557-90
Phenobarbital	Phenobarbital 97.2 mg/1	TabletOral	Chartwell RX, LLC	62135-558	62135-0558-90
Phenobarbital	Phenobarbital 15 mg/1	TabletOral	Chartwell RX, LLC	62135-510	62135-0510-90
Phenobarbital	Phenobarbital 30 mg/1	TabletOral	Chartwell RX, LLC	62135-514	62135-0514-90
Phenobarbital	Phenobarbital 60 mg/1	TabletOral	Chartwell RX, LLC	62135-515	62135-0515-90
Phenobarbital	Phenobarbital 100 mg/1	TabletOral	Chartwell RX, LLC	62135-519	62135-0519-90
Phenobarbital	Phenobarbital 16.2 mg/1	TabletOral	Chartwell RX, LLC	62135-539	62135-0539-90
Phenobarbital	Phenobarbital 32.4 mg/1	TabletOral	Chartwell RX, LLC	62135-554	62135-0554-90
Phenobarbital	Phenobarbital 16.2 mg/1	TabletOral	REMEDYREPACK INC.	70518-4719	70518-4719-00
Phenobarbital	Phenobarbital 64.8 mg/1	TabletOral	REMEDYREPACK INC.	70518-4717	70518-4717-00

All 153 Phenobarbital NDCs