NDC codes

FDA NDC Directory
Product NDC (as listed)11584-0030Labeler and product segments. Claims need a package NDC.
Product NDC at billing width11584-0030Add 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 NDC11-digit (billing)PackageCopy
11584-0030-111584003001100 TABLET in 1 BOTTLE, PLASTIC (11584-0030-1)Marketed from Oct 10, 2013

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Tencon
Generic name (nonproprietary)
butalbital and acetaminophen
Active ingredients
Butalbital50 mg/1Acetaminophen325 mg/1
Dosage form
Tablet
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 089987
Marketing start
Listing expires
Other FDA classes
Barbiturates (Chemical structure)
Identifiers
Product ID 11584-0030_18834fb3-9eae-0e94-e063-6394a90accfbSPL ID 18834fb3-9eae-0e94-e063-6394a90accfbSPL set ID 4e4a9925-67aa-4be7-8bb7-c8b058ffe223RxCUI 197426, 1483329UNII KHS0AZ4JVK, 362O9ITL9DUPC 0311584003012
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

N411584003001 followed by a unit qualifier and the quantity

Package 11584-0030-01. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Tencon (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)

Other NDCs under ANDA 089987

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

FDA NDC Directory listings under ANDA 089987
ProductStrengthForm · routeLabelerProduct NDC
butalbital and acetaminophenButalbital 50 mg/1; Acetaminophen 325 mg/1TabletOralPar Health0603-2540

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