What is NDC 64850-631?

64850-631 is the product NDC for Hydrocodone Bitartrate and Acetaminophen, Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Elite Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Hydrocodone bitartrate, Acetaminophen.

Elite Laboratories, Inc., NDC labeler code 64850. 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 64850-631

NDC codes

FDA NDC Directory

Product NDC (as listed)64850-631Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64850-0631Add 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
64850-631-01	6485006310164850063101	100 TABLET in 1 BOTTLE, PLASTIC (64850-631-01)Marketed from Nov 16, 2018

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: Elite Laboratories, Inc.NDC labeler code 64850
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209924
Marketing start: Nov 16, 2018
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 64850-631_91acad07-a9ce-450e-b9f6-4401b89bd32cSPL ID 91acad07-a9ce-450e-b9f6-4401b89bd32cSPL set ID 89b8145f-5310-4b58-a65d-586dc90d642dRxCUI 856999, 857002, 857005, 857391UNII 362O9ITL9D, NO70W886KKUPC 0364850630016, 0364850633017, 0364850632010, 0364850631013
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

N464850063101 followed by a unit qualifier and the quantity

Package 64850-0631-01. 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 Oct 23, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & 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 64850-631

What is NDC 64850-631?: 64850-631 is the product NDC for Hydrocodone Bitartrate and Acetaminophen, Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Elite Laboratories, Inc.. 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?: Elite Laboratories, Inc., NDC labeler code 64850. 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 209924

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

FDA NDC Directory listings under ANDA 209924
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 2.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Elite Laboratories, Inc.	64850-630
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 7.5 mg/1; Acetaminophen 325 mg/1	TabletOral	Elite Laboratories, Inc.	64850-632
Hydrocodone Bitartrate and Acetaminophen	Hydrocodone bitartrate 10 mg/1; Acetaminophen 325 mg/1	TabletOral	Elite Laboratories, Inc.	64850-633