Prescription drug · ANDA
Allzital (Butalbital and acetaminophen) NDC 68047-752
Butalbital 25 mg/1; Acetaminophen 325 mg/1 · Tablet · Oral · Larken Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68047-752-01 | 6804707520168047075201 | 100 TABLET in 1 BOTTLE (68047-752-01)Marketed from Dec 4, 2015 | |
| 68047-752-30 | 6804707523068047075230 | 30 TABLET in 1 BOTTLE (68047-752-30)Marketed from Dec 4, 2015 |
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)
- Allzital
- Generic name (nonproprietary)
- butalbital and acetaminophen
- Active ingredients
- Butalbital — 25 mg/1Acetaminophen — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Larken Laboratories, Inc.NDC labeler code 68047
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203484
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Barbiturates (Chemical structure)
- Identifiers
- Product ID 68047-752_41348343-4fef-7234-e063-6394a90af41dSPL ID 41348343-4fef-7234-e063-6394a90af41dSPL set ID 326c83fc-afed-45ad-9c87-f47968fa1d2aRxCUI 197426, 1724446, 2279007UNII 362O9ITL9D, KHS0AZ4JVKUPC 0368047753014, 0368047752017, 0368047721013
- 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
N468047075201followed by a unit qualifier and the quantityPackage 68047-0752-01. 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 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 68047-752
- What is NDC 68047-752?
- 68047-752 is the product NDC for Allzital, Butalbital 25 mg/1; Acetaminophen 325 mg/1 tablet, listed with the FDA by Larken Laboratories, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Allzital (Butalbital and acetaminophen).
- What is the active ingredient?
- Butalbital, Acetaminophen.
- Who is the labeler?
- Larken Laboratories, Inc., NDC labeler code 68047. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Allzital?
- 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 203484
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 | Larken Laboratories, Inc. | 68047-721 |
| Butalbital and Acetaminophen | Butalbital 25 mg/1; Acetaminophen 325 mg/1 | TabletOral | Larken Laboratories, Inc. | 68047-753 |