What is NDC 82804-116?

82804-116 is the product NDC for Hydrocodone Bitartrate And Acetaminophen, Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Hydrocodone bitartrate, Acetaminophen.

Proficient Rx LP, NDC labeler code 82804. 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?

201 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 82804-116

NDC codes

FDA NDC Directory

Product NDC (as listed)82804-116Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82804-0116Add 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
82804-116-12	8280401161282804011612	12 TABLET in 1 BOTTLE (82804-116-12)Marketed from Jul 2, 2024

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: Proficient Rx LPNDC labeler code 82804
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040409
Marketing start: Oct 20, 2000
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 82804-116_9bad45b7-32ce-47aa-bfdf-8e6a75513056SPL ID 9bad45b7-32ce-47aa-bfdf-8e6a75513056SPL set ID 9bad45b7-32ce-47aa-bfdf-8e6a75513056RxCUI 857002UNII NO70W886KK, 362O9ITL9DUPC 0382804116126
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

N482804011612 followed by a unit qualifier and the quantity

Package 82804-0116-12. 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 1, 2024. 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 tablets…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82804-116

What is NDC 82804-116?: 82804-116 is the product NDC for Hydrocodone Bitartrate And Acetaminophen, Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Proficient Rx LP. 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?: Proficient Rx LP, NDC labeler code 82804. 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?: 201 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 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	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 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Proficient Rx LP	82804-306	82804-0306-12
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 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 10 mg/15mL; Acetaminophen 300 mg/15mL	LiquidOral	Hikma Pharmaceuticals USA Inc.	0054-0843	00054-0843-63

All 202 Hydrocodone Bitartrate And Acetaminophen NDCs

Other NDCs under ANDA 040409

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

FDA NDC Directory listings under ANDA 040409
Product	Strength	Form · route	Labeler	Product NDC
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	SpecGx LLC	0406-0123
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	A-S Medication Solutions	50090-1778
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Quality Care Products, LLC	55700-992
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-590
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-870
Hydrocodone Bitartrate And Acetaminophen	Hydrocodone bitartrate 5 mg/1; Acetaminophen 325 mg/1	TabletOral	RedPharm Drug, Inc	67296-1890
Hydrocodone/APAP	Acetaminophen 325 mg/1; Hydrocodone bitartrate 5 mg/1	TabletOral	Direct_Rx	72189-407