What is NDC 63304-506?

63304-506 is the product NDC for pentazocine and naloxone, Pentazocine 50 mg/1; Naloxone hydrochloride .5 mg/1 tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Pentazocine, Naloxone hydrochloride.

Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for pentazocine and naloxone?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

pentazocine and naloxone NDC 63304-506

NDC codes

FDA NDC Directory

Product NDC (as listed)63304-506Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63304-0506Add 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
63304-506-01	63304050601	100 TABLET in 1 BOTTLE (63304-506-01)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): pentazocine and naloxone
Generic name (nonproprietary): pentazocine and naloxone
Active ingredients: Pentazocine — 50 mg/1Naloxone hydrochloride — .5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 63304
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075523
Marketing start: Jul 31, 2018
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Competitive Opioid Antagonists (Mechanism)Opioid Antagonists (Mechanism)Partial Opioid Agonists (Mechanism)
Identifiers: Product ID 63304-506_48ee2bd7-f7c9-4bf8-8932-ba9065c64cf3SPL ID 48ee2bd7-f7c9-4bf8-8932-ba9065c64cf3SPL set ID 41ebdaaf-3bbc-419f-b996-0341efc14623RxCUI 312289UNII RP4A60D26L, F850569PQRUPC 0363304506013
Pharmacologic class: Opioid Antagonist; Partial Opioid Agonist/Antagonist

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

N463304050601 followed by a unit qualifier and the quantity

Package 63304-0506-01. 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 Pentazocine and Naloxone Hydrochloride 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, even at recommended doses, reserve Pentazocine and Naloxone 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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63304-506

What is NDC 63304-506?: 63304-506 is the product NDC for pentazocine and naloxone, Pentazocine 50 mg/1; Naloxone hydrochloride .5 mg/1 tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: pentazocine and naloxone.
What is the active ingredient?: Pentazocine, Naloxone hydrochloride.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 63304. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for pentazocine and naloxone?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.