What is NDC 0121-1049?

0121-1049 is the product NDC for Glycerol Phenylbutyrate, Glycerol phenylbutyrate 1.1 g/mL liquid, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.

PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Glycerol Phenylbutyrate?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Glycerol Phenylbutyrate NDC 0121-1049

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-1049Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-1049Add 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
0121-1049-25	0012110492500121104925	1 BOTTLE in 1 CARTON (0121-1049-25) / 25 mL in 1 BOTTLEMarketed from Oct 12, 2026

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): Glycerol Phenylbutyrate
Generic name (nonproprietary): glycerol phenylbutyrate
Active ingredients: Glycerol phenylbutyrate — 1.1 g/mL
Dosage form: Liquid
Route: Oral
Labeler: PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 220579
Marketing start: Oct 12, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Ammonium Ion Binding Activity (Mechanism)
Identifiers: Product ID 0121-1049_8e05336e-2d56-44e5-a76b-5b39f2f26a0fSPL ID 8e05336e-2d56-44e5-a76b-5b39f2f26a0f
Pharmacologic class: Nitrogen Binding Agent

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

N400121104925 followed by a unit qualifier and the quantity

Package 00121-1049-25. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0121-1049

What is NDC 0121-1049?: 0121-1049 is the product NDC for Glycerol Phenylbutyrate, Glycerol phenylbutyrate 1.1 g/mL liquid, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Glycerol Phenylbutyrate.
What is the active ingredient?: Glycerol phenylbutyrate.
Who is the labeler?: PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Glycerol Phenylbutyrate?: 8 other product NDCs are listed under this name. See all Glycerol Phenylbutyrate 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 Glycerol Phenylbutyrate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Glycerol Phenylbutyrateglycerol phenylbutyrate oral	Glycerol phenylbutyrate 1.1 g/mL	LiquidOral	Camber Pharmaceuticals, Inc.	31722-605	31722-0605-3131722-0605-32
Glycerol Phenylbutyrate	Glycerol phenylbutyrate 1.1 g/mL	LiquidOral	Navinta LLC	68475-807	68475-0807-01
Glycerol Phenylbutyrate	Glycerol phenylbutyrate 1.1 g/mL	LiquidOral	Zydus Pharmaceuticals USA Inc.	70710-2193	70710-2193-05
Glycerol phenylbutyrate	Glycerol phenylbutyrate 1.1 g/mL	LiquidOral	Teva Pharmaceuticals, Inc.	0480-3777	00480-3777-58
Glycerol Phenylbutyrate	Glycerol phenylbutyrate 1.1 g/mL	LiquidOral	Aurobindo Pharma Limited	59651-988	59651-0988-25
Glycerol phenylbutyrate	Glycerol phenylbutyrate 1.1 g/mL	LiquidOral	Novadoz Pharmaceuticals LLC	72205-331	72205-0331-5772205-0331-58
glycerol phenylbutyrate	Glycerol phenylbutyrate 1.1 g/mL	LiquidOral	Lupin Pharmaceuticals, Inc.	70748-425	70748-0425-01
Glycerol Phenylbutyrateglycerol phenylbutyrate oral	Glycerol phenylbutyrate 1.1 g/mL	LiquidOral	Par Health USA, LLC	49884-264	49884-0264-95