Hydrocodone Bitartrate and Acetaminophen NDC 63304-497

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-497Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0497Add 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
63304-497-01	63304049701	100 TABLET in 1 BOTTLE (63304-497-01)Marketed from Jul 31, 2018
63304-497-03	63304049703	10 TABLET in 1 BOTTLE (63304-497-03)Marketed from Jul 31, 2018
63304-497-05	63304049705	500 TABLET in 1 BOTTLE (63304-497-05)Marketed from Jul 31, 2018
63304-497-10	63304049710	1000 TABLET in 1 BOTTLE (63304-497-10)Marketed from Jul 31, 2018
63304-497-69	63304049769	10 BLISTER PACK in 1 CARTON (63304-497-69) / 1 TABLET in 1 BLISTER PACK (63304-497-11)Marketed from Jul 31, 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: Acetaminophen — 325 mg/1Hydrocodone bitartrate — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 040826
Marketing start: Jul 31, 2018
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Opioid Agonists (Mechanism)
Identifiers: Product ID 63304-497_4f875c7a-4454-45a2-bf55-fcc2932c51dbSPL ID 4f875c7a-4454-45a2-bf55-fcc2932c51dbSPL set ID 6e153073-ca78-481e-9e9c-0365ee3f3d59RxCUI 856999UNII 362O9ITL9D, NO70W886KKUPC 0363304497014
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

N463304049701 followed by a unit qualifier and the quantity

Package 63304-0497-01. 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 31, 2018. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the management of moderate to moderately severe 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, even at recommended doses [see WARNINGS ], reserve Hydrocodone Bitartrate and Acetaminophen Tablets, USP 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)