What is NDC 0121-1544?

0121-1544 is the product NDC for Hydrocodone Bitartrate and Acetaminophen, Hydrocodone bitartrate 5 mg/10mL; Acetaminophen 217 mg/10mL solution, 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 is the active ingredient?

Hydrocodone bitartrate, Acetaminophen.

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 Hydrocodone Bitartrate and Acetaminophen?

202 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Hydrocodone Bitartrate and Acetaminophen NDC 0121-1544

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-1544Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-1544Add 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
0121-1544-40	0012115444000121154440	4 TRAY in 1 CASE (0121-1544-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1544-10)Marketed from Jul 29, 2013

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): Hydrocodone Bitartrate and Acetaminophen
Generic name (nonproprietary): hydrocodone bitartrate and acetaminophen
Active ingredients: Hydrocodone bitartrate — 5 mg/10mLAcetaminophen — 217 mg/10mL
Dosage form: Solution
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 040838
Marketing start: Jul 29, 2013
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 0121-1544_1c5f2752-d5b9-4830-bc53-31c816f2bc09SPL ID 1c5f2752-d5b9-4830-bc53-31c816f2bc09SPL set ID c29b97e9-8097-4d87-a420-ccf5aec8274aRxCUI 856940UNII 362O9ITL9D, NO70W886KK
Pharmacologic class: Opioid 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

N400121154440 followed by a unit qualifier and the quantity

Package 00121-1544-40. 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 2, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Oral Solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS ], reserve opioid analgesics, including Hydrocodone Bitartrate and Acetaminophen Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-1544

What is NDC 0121-1544?: 0121-1544 is the product NDC for Hydrocodone Bitartrate and Acetaminophen, Hydrocodone bitartrate 5 mg/10mL; Acetaminophen 217 mg/10mL solution, 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?: Hydrocodone Bitartrate and Acetaminophen.
What is the active ingredient?: Hydrocodone bitartrate, Acetaminophen.
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 Hydrocodone Bitartrate and Acetaminophen?: 202 other product NDCs are listed under this name. See all Hydrocodone Bitartrate and Acetaminophen 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 Hydrocodone Bitartrate and Acetaminophen NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-873	60760-0873-3060760-0873-60
Hydrocodone Bitartrate and Acetaminophen	Acetaminophen 325 mg/1; Hydrocodone bitartrate 10 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-872	60760-0872-3060760-0872-60
hydrocodone bitartrate and acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Strides Pharma Science Limited	64380-440	64380-0440-01
hydrocodone bitartrate and acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Strides Pharma Science Limited	64380-441	64380-0441-01
hydrocodone bitartrate and acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Strides Pharma Science Limited	64380-442	64380-0442-01
hydrocodone bitartrate and acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	82804-306	82804-0306-12
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 2.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-940	31722-0940-01
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Camber Pharmaceuticals, Inc.	31722-942	31722-0942-0131722-0942-05
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-870	60760-0870-3060760-0870-60
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 10 mg/15mL; Acetaminophen 300 mg/15mL	LiquidOral	Hikma Pharmaceuticals USA Inc.	0054-0843	00054-0843-63

All 203 Hydrocodone Bitartrate and Acetaminophen NDCs

Other NDCs under ANDA 040838

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

FDA NDC Directory listings under ANDA 040838
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-2316
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 2.5 mg/5mL; Acetaminophen 108 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-4772
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL	SolutionOral	Genus Lifesciences Inc.	64950-373
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/15mL; Acetaminophen 325 mg/15mL	SolutionOral	Redpharm drug	67296-2093