What is NDC 13107-019?

13107-019 is the product NDC for Hydrocodone Bitartrate and Acetaminophen, Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Aurolife Pharma, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Hydrocodone bitartrate, Acetaminophen.

Aurolife Pharma, LLC, NDC labeler code 13107. 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 13107-019

NDC codes

FDA NDC Directory

Product NDC (as listed)13107-019Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13107-0019Add 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
13107-019-01	1310700190113107001901	100 TABLET in 1 BOTTLE (13107-019-01)Marketed from Apr 11, 2012
13107-019-05	1310700190513107001905	500 TABLET in 1 BOTTLE (13107-019-05)Marketed from Apr 11, 2012
13107-019-30	1310700193013107001930	30 TABLET in 1 BOTTLE (13107-019-30)Marketed from Apr 11, 2012
13107-019-99	1310700199913107001999	1000 TABLET in 1 BOTTLE (13107-019-99)Marketed from Apr 11, 2012

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): Hydrocodone Bitartrate and Acetaminophen
Generic name (nonproprietary): hydrocodone bitartrate and acetaminophen
Active ingredients: Hydrocodone bitartrate — 5 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aurolife Pharma, LLCNDC labeler code 13107
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201013
Marketing start: Apr 11, 2012
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 13107-019_7f417649-a59e-4737-9535-ef865ab1f076SPL ID 7f417649-a59e-4737-9535-ef865ab1f076SPL set ID 60f43308-1deb-4f05-8f17-aa49ebdcf498RxCUI 856999, 857002, 857005UNII 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

N413107001901 followed by a unit qualifier and the quantity

Package 13107-0019-01. 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 Dec 11, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hydrocodone bitartrate and acetaminophen tablets are 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 tablets 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 13107-019

What is NDC 13107-019?: 13107-019 is the product NDC for Hydrocodone Bitartrate and Acetaminophen, Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Aurolife Pharma, LLC. It has 4 package NDCs, 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?: Aurolife Pharma, LLC, NDC labeler code 13107. 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 201013

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

FDA NDC Directory listings under ANDA 201013
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Aurolife Pharma, LLC	13107-020
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Aurolife Pharma, LLC	13107-021
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	63187-375
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	63187-658
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	63187-778
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	66267-319
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4801
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4853
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-4941
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-0108
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1271
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Bryant Ranch Prepack	71335-1339