Prescription drug · ANDA
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate NDC 0054-0650
Butalbital 50 mg/1 + 3 more ingredients · Capsule · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0650-25 | 0005406502500054065025 | 100 CAPSULE in 1 BOTTLE (0054-0650-25)Marketed from May 9, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Acetaminophen, Caffeine and Codeine Phosphate
- Generic name (nonproprietary)
- butalbital, acetaminophen, caffeine and codeine phosphate
- Active ingredients
- Butalbital — 50 mg/1Acetaminophen — 300 mg/1Caffeine — 40 mg/1Codeine phosphate — 30 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215138
- 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 0054-0650_3477a730-97ec-460b-9e7f-0fd5e84c4404SPL ID 3477a730-97ec-460b-9e7f-0fd5e84c4404SPL set ID 6e0e8abc-512b-42f7-8323-434c589edecfRxCUI 993943, 1431286UNII GSL05Y1MN6, 362O9ITL9D, KHS0AZ4JVK, 3G6A5W338EUPC 0300540650254, 0300543000018
- 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
N400054065025followed by a unit qualifier and the quantityPackage 00054-0650-25. 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, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, [see Warnings and Precautions ( 5.1 )] , reserve opioid analgesics, including Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide suffic…
Excerpt only. Read the full label for complete information.
About NDC 0054-0650
- What is NDC 0054-0650?
- 0054-0650 is the product NDC for Butalbital, Acetaminophen, Caffeine and Codeine Phosphate, Butalbital 50 mg/1 + 3 more ingredients capsule, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, 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?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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. | 0054-3000 | 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 | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | LGM PHARMA SOLUTIONS, LLC | 79739-6670 | 79739-6670-0179739-6670-05 |
| 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 215138
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 | Hikma Pharmaceuticals USA Inc. | 0054-3000 |