Prescription drug · ANDA
Butalbital, Acetaminophen, and Caffeine NDC 63629-8392
Butalbital 50 mg/1 + 2 more ingredients · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8392-0 | 6362983920063629839200 | 84 TABLET in 1 BOTTLE (63629-8392-0)Marketed from Oct 29, 2024 | |
| 63629-8392-1 | 6362983920163629839201 | 20 TABLET in 1 BOTTLE (63629-8392-1)Marketed from Oct 29, 2024 | |
| 63629-8392-2 | 6362983920263629839202 | 30 TABLET in 1 BOTTLE (63629-8392-2)Marketed from Dec 9, 2020 | |
| 63629-8392-3 | 6362983920363629839203 | 60 TABLET in 1 BOTTLE (63629-8392-3)Marketed from Dec 9, 2020 | |
| 63629-8392-4 | 6362983920463629839204 | 90 TABLET in 1 BOTTLE (63629-8392-4)Marketed from Jan 20, 2021 | |
| 63629-8392-5 | 6362983920563629839205 | 50 TABLET in 1 BOTTLE (63629-8392-5)Marketed from Oct 29, 2024 | |
| 63629-8392-6 | 6362983920663629839206 | 6 TABLET in 1 BOTTLE (63629-8392-6)Marketed from Oct 29, 2024 | |
| 63629-8392-7 | 6362983920763629839207 | 120 TABLET in 1 BOTTLE (63629-8392-7)Marketed from Oct 29, 2024 | |
| 63629-8392-8 | 6362983920863629839208 | 40 TABLET in 1 BOTTLE (63629-8392-8)Marketed from Oct 29, 2024 | |
| 63629-8392-9 | 6362983920963629839209 | 12 TABLET in 1 BOTTLE (63629-8392-9)Marketed from Dec 8, 2020 |
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, and Caffeine
- Generic name (nonproprietary)
- butalbital, acetaminophen, and caffeine
- Active ingredients
- Butalbital — 50 mg/1Acetaminophen — 325 mg/1Caffeine — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200243
- Marketing start
- Listing expires
- DEA schedule
- CIII
- Other FDA classes
- Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
- Identifiers
- Product ID 63629-8392_7892fec9-6783-40c3-87f4-308676ed63f3SPL ID 7892fec9-6783-40c3-87f4-308676ed63f3SPL set ID 5b918d6b-94b0-4f9a-ab09-6a511b727de0RxCUI 238154UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338E
- Pharmacologic class
- Barbiturate; Central Nervous System Stimulant; Methylxanthine
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
N463629839200followed by a unit qualifier and the quantityPackage 63629-8392-00. 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, acetaminophen, and caffeine tablets, USP 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 63629-8392
- What is NDC 63629-8392?
- 63629-8392 is the product NDC for Butalbital, Acetaminophen, and Caffeine, Butalbital 50 mg/1 + 2 more ingredients tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Butalbital, Acetaminophen, and Caffeine.
- What is the active ingredient?
- Butalbital, Acetaminophen, Caffeine.
- Who is the labeler?
- Bryant Ranch Prepack, NDC labeler code 63629. 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, and Caffeine?
- 50 other product NDCs are listed under this name. See all Butalbital, Acetaminophen, and Caffeine 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, and Caffeine 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 and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4126 | 68788-4126-0268788-4126-03 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | REMEDYREPACK INC. | 70518-4601 | 70518-4601-0070518-4601-0170518-4601-02 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Amici Pharma, Inc. | 69292-305 | 69292-0305-01 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0567 | 80425-0567-0180425-0567-0280425-0567-03 |
| Butalbital, Acetaminophen and Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/15mL + 2 more ingredients | SolutionOral | Genus Lifesciences Inc. | 64950-290 | 64950-0290-16 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0497 | 80425-0497-01 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8794 | 68788-8794-0268788-8794-03 |
| butalbital, acetaminophen and caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Dr. Reddy's Labratories Inc. | 75907-009 | 75907-0009-01 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | QUAGEN PHARMACEUTICALS LLC | 70752-142 | 70752-0142-1070752-0142-14 |
| Butalbital, Acetaminophen And Caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | QUAGEN PHARMACEUTICALS LLC | 70752-144 | 70752-0144-1070752-0144-14 |
Other NDCs under ANDA 200243
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, and Caffeine | Acetaminophen 325 mg/1 + 2 more ingredients | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3249 |
| Butalbital, Acetaminophen, and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | REMEDYREPACK INC. | 70518-1134 |
| Butalbital, Acetaminophen, and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Lannett Company, Inc. | 0527-1695 |
| Butalbital, Acetaminophen, and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Cardinal Health 107, LLC | 55154-3356 |
| Butal/APAP/Caff | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Direct_Rx | 72189-441 |
| Butalbital, Acetaminophen, and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Major Pharmaceuticals | 0904-6938 |
| Butalbital, Acetaminophen, and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Proficient Rx LP | 63187-933 |