Prescription drug · ANDA
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate NDC 71335-0194
Butalbital 50 mg/1 + 3 more ingredients · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0194-1 | 7133501940171335019401 | 20 CAPSULE in 1 BOTTLE (71335-0194-1)Marketed from Dec 27, 2021 | |
| 71335-0194-2 | 7133501940271335019402 | 90 CAPSULE in 1 BOTTLE (71335-0194-2)Marketed from Aug 30, 2019 | |
| 71335-0194-3 | 7133501940371335019403 | 30 CAPSULE in 1 BOTTLE (71335-0194-3)Marketed from Dec 27, 2021 | |
| 71335-0194-4 | 7133501940471335019404 | 60 CAPSULE in 1 BOTTLE (71335-0194-4)Marketed from Dec 13, 2021 | |
| 71335-0194-5 | 7133501940571335019405 | 100 CAPSULE in 1 BOTTLE (71335-0194-5)Marketed from Dec 27, 2021 | |
| 71335-0194-6 | 7133501940671335019406 | 15 CAPSULE in 1 BOTTLE (71335-0194-6)Marketed from Dec 27, 2021 | |
| 71335-0194-7 | 7133501940771335019407 | 18 CAPSULE in 1 BOTTLE (71335-0194-7)Marketed from Dec 27, 2021 |
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
- Bryant Ranch PrepackNDC labeler code 71335
- 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 71335-0194_ab86ae24-3103-4976-bd9d-8c90b76c5f29SPL ID ab86ae24-3103-4976-bd9d-8c90b76c5f29SPL set ID 15a34df5-e48f-4570-9232-80e4093c4624RxCUI 993943UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338E, GSL05Y1MN6
- 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
N471335019401followed by a unit qualifier and the quantityPackage 71335-0194-01. 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. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsule is a combination product of butalbital, a barbiturate; acetaminophen; caffeine, a methylxanthine; and codeine phosphate, an opioid agonist; and is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when other non-opioid analgesic and alternative treatments are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, and misuse…
Excerpt only. Read the full label for complete information.
About NDC 71335-0194
- What is NDC 71335-0194?
- 71335-0194 is the product NDC for Butalbital, Acetaminophen, Caffeine and Codeine Phosphate, Butalbital 50 mg/1 + 3 more ingredients capsule, listed with the FDA by Bryant Ranch Prepack. It has 7 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 | 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 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 | 72162-1591 |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | Actavis Pharma, Inc. | 0591-2641 |
| Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate | Butalbital 50 mg/1 + 3 more ingredients | CapsuleOral | LGM PHARMA SOLUTIONS, LLC | 79739-6670 |