Prescription drug · ANDA
Tencon (Butalbital and acetaminophen) NDC 11584-0030
Butalbital 50 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · El Dorado Distributors LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11584-0030-1 | 1158400300111584003001 | 100 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
- Butalbital — 50 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- El Dorado Distributors LLCNDC labeler code 11584
- 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
N411584003001followed by a unit qualifier and the quantityPackage 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.
About NDC 11584-0030
- What is NDC 11584-0030?
- 11584-0030 is the product NDC for Tencon, Butalbital 50 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by El Dorado Distributors LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tencon (Butalbital and acetaminophen).
- What is the active ingredient?
- Butalbital, Acetaminophen.
- Who is the labeler?
- El Dorado Distributors LLC, NDC labeler code 11584. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tencon?
- 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.
Other NDCs under ANDA 089987
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| butalbital and acetaminophen | Butalbital 50 mg/1; Acetaminophen 325 mg/1 | TabletOral | Par Health | 0603-2540 |