Prescription drug · ANDA
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate NDC 79739-6670
Butalbital 50 mg/1 + 3 more ingredients · Capsule · Oral · LGM PHARMA SOLUTIONS, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 79739-6670-1 | 7973966700179739667001 | 100 CAPSULE in 1 BOTTLE, PLASTIC (79739-6670-1)Marketed from Jun 10, 2004 | |
| 79739-6670-5 | 7973966700579739667005 | 500 CAPSULE in 1 BOTTLE, PLASTIC (79739-6670-5)Marketed from Jun 10, 2004 |
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)
- Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
- Generic name (nonproprietary)
- butalbital, acetaminophen, caffeine, and codeine phosphate
- Active ingredients
- Butalbital — 50 mg/1Acetaminophen — 325 mg/1Caffeine — 40 mg/1Codeine phosphate — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- LGM PHARMA SOLUTIONS, LLCNDC labeler code 79739
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076560
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Full Opioid Agonists (Mechanism)Xanthines (Chemical structure)
- Identifiers
- Product ID 79739-6670_20dc9c68-50ed-4c48-a516-d5b82b3654a6SPL ID 20dc9c68-50ed-4c48-a516-d5b82b3654a6SPL set ID 180d20a5-78a8-4faa-98ad-3196cdd5663aRxCUI 993943UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338E, GSL05Y1MN6UPC 0379739667014
- Pharmacologic class
- Barbiturate; Central Nervous System Stimulant; Methylxanthine; Opioid Agonist
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
N479739667001followed by a unit qualifier and the quantityPackage 79739-6670-01. 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)
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules are indicated for the management of the symptom complex of tension (or muscle contraction) headache when non opioid analgesic and alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids and butalbital, even at recommended doses [see Warnings and Precautions ( 5.1 )] , reserve Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for use in patients for whom alternative treatment options [e.g., non-opioid, non-barbiturate analgesics]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not e…
Excerpt only. Read the full label for complete information.
About NDC 79739-6670
- What is NDC 79739-6670?
- 79739-6670 is the product NDC for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate, Butalbital 50 mg/1 + 3 more ingredients capsule, listed with the FDA by LGM PHARMA SOLUTIONS, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate.
- What is the active ingredient?
- Butalbital, Acetaminophen, Caffeine, Codeine phosphate.
- Who is the labeler?
- LGM PHARMA SOLUTIONS, LLC, NDC labeler code 79739. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate?
- 7 other product NDCs are listed under this name. See all Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-0650 | 00054-0650-25 |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Hikma Pharmaceuticals USA Inc. | 0054-3000 | 00054-3000-01 |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Actavis Pharma, Inc. | 0591-2641 | 00591-2641-01 |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Breckenridge Pharmaceutical, Inc. | 51991-073 | 51991-0073-01 |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Bryant Ranch Prepack | 71335-0194 | 71335-0194-0171335-0194-0271335-0194-03+4 more |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Bryant Ranch Prepack | 72162-1591 | 72162-1591-02 |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Codeine phosphate 30 mg/1 + 3 more ingredients | CapsuleOral | Actavis Pharma, Inc. | 0591-3220 | 00591-3220-01 |
Other NDCs under ANDA 076560
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, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Breckenridge Pharmaceutical, Inc. | 51991-073 |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Bryant Ranch Prepack | 71335-0194 |
| Butalbital, Acetaminophen, Caffeine and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Bryant Ranch Prepack | 72162-1591 |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Actavis Pharma, Inc. | 0591-2641 |