What is NDC 0245-0412?

0245-0412 is the product NDC for Hydrocodone Bitartrate and Acetaminophen, Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Hydrocodone bitartrate, Acetaminophen.

Upsher-Smith Laboratories, LLC, NDC labeler code 0245. 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 0245-0412

NDC codes

FDA NDC Directory

Product NDC (as listed)0245-0412Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00245-0412Add 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
0245-0412-01	0024504120100245041201	100 BLISTER PACK in 1 CARTON (0245-0412-01) / 1 TABLET in 1 BLISTER PACK (0245-0412-89)Marketed from Mar 27, 2017
0245-0412-11	0024504121100245041211	100 TABLET in 1 BOTTLE (0245-0412-11)Marketed from Mar 27, 2017
0245-0412-50	0024504125000245041250	500 TABLET in 1 BOTTLE (0245-0412-50)Marketed from Mar 27, 2017

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 — 10 mg/1Acetaminophen — 325 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Upsher-Smith Laboratories, LLCNDC labeler code 0245
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206484
Marketing start: Mar 27, 2017
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 0245-0412_39e7eaec-9677-7a63-e063-6394a90a520eSPL ID 39e7eaec-9677-7a63-e063-6394a90a520eSPL set ID 3aa0b733-b58f-46bd-8e76-37ddf1dc3356RxCUI 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

N400245041201 followed by a unit qualifier and the quantity

Package 00245-0412-01. 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 Jul 14, 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, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS ], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): have not been tolerated, or are not expected to be tolerated, have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydrocodone Bitartrate and Acetaminophen Tablet…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0245-0412

What is NDC 0245-0412?: 0245-0412 is the product NDC for Hydrocodone Bitartrate and Acetaminophen, Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 3 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?: Upsher-Smith Laboratories, LLC, NDC labeler code 0245. 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 206484

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

FDA NDC Directory listings under ANDA 206484
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Upsher-Smith Laboratories, LLC	0245-0410
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Upsher-Smith Laboratories, LLC	0245-0411