Butalbital and Acetaminophen NDC 68682-306

NDC codes

FDA NDC Directory

Product NDC (as listed)68682-306Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68682-0306Add 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
68682-306-01	68682030601	100 TABLET in 1 BOTTLE, PLASTIC (68682-306-01)Marketed from Jun 19, 2017

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): Butalbital and Acetaminophen
Generic name (nonproprietary): butalbital and acetaminophen tablets
Active ingredients: Butalbital — 50 mg/1Acetaminophen — 300 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Oceanside Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090956
Marketing start: Jun 19, 2017
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Barbiturates (Chemical structure)
Identifiers: Product ID 68682-306_3f21cb4d-0b19-441c-a6df-2c3077e1fedeSPL ID 3f21cb4d-0b19-441c-a6df-2c3077e1fedeSPL set ID d2213ffd-18f6-45f5-9af7-690a977562c4RxCUI 1249617UNII KHS0AZ4JVK, 362O9ITL9DUPC 0368682306019
Pharmacologic class: Barbiturate

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

N468682030601 followed by a unit qualifier and the quantity

Package 68682-0306-01. 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 Apr 2, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Butalbital and Acetaminophen Tablets are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)