Prescription drug · ANDA
Butalbital, Acetaminophen, Caffeine (Butalbital, acetaminophen, and caffeine) NDC 68788-8137
Butalbital 50 mg/1 + 2 more ingredients · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8137-2 | 6878881370268788813702 | 20 TABLET in 1 BOTTLE (68788-8137-2)Marketed from Feb 11, 2022 | |
| 68788-8137-3 | 6878881370368788813703 | 30 TABLET in 1 BOTTLE (68788-8137-3)Marketed from Feb 11, 2022 |
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
- 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
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209587
- 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 68788-8137_65e8a200-10ba-4f9e-8d4a-ad5977105686SPL ID 65e8a200-10ba-4f9e-8d4a-ad5977105686SPL set ID b121190e-db2a-43bb-a57d-b6683a9e2059RxCUI 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
N468788813702followed by a unit qualifier and the quantityPackage 68788-8137-02. 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 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 68788-8137
- What is NDC 68788-8137?
- 68788-8137 is the product NDC for Butalbital, Acetaminophen, Caffeine, Butalbital 50 mg/1 + 2 more ingredients tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Butalbital, Acetaminophen, Caffeine (Butalbital, Acetaminophen, and Caffeine).
- What is the active ingredient?
- Butalbital, Acetaminophen, Caffeine.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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?
- 12 other product NDCs are listed under this name. See all Butalbital, Acetaminophen, 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, 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, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0570 | 80425-0570-0180425-0570-0280425-0570-03 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | REMEDYREPACK INC. | 70518-4309 | 70518-4309-0070518-4309-01 |
| Butalbital/Acetaminophen/Caffeine | Butalbital 50 mg/1 + 2 more ingredients | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0215 | 80425-0215-01 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | AvPAK | 50268-553 | 50268-0553-13 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | A-S Medication Solutions | 50090-7042 | 50090-7042-0050090-7042-03 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Westminster Pharmaceuticals, LLC | 69367-203 | 69367-0203-0169367-0203-05 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Proficient Rx LP | 71205-510 | 71205-0510-1471205-0510-3071205-0510-60+1 more |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Proficient Rx LP | 71205-981 | 71205-0981-0071205-0981-3071205-0981-55+3 more |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Bryant Ranch Prepack | 71335-1764 | 71335-1764-0071335-1764-0171335-1764-02+7 more |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Bryant Ranch Prepack | 71335-1767 | 71335-1767-0071335-1767-0171335-1767-02+7 more |
Other NDCs under ANDA 209587
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 |
|---|---|---|---|---|
| Butal/Apap/Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Direct_Rx | 72189-600 |
| Butalbital, Acetaminophen, and Caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | LGM PHARMA SOLUTIONS, LLC | 79739-7320 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | A-S Medication Solutions | 50090-7042 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | AvPAK | 50268-553 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Westminster Pharmaceuticals, LLC | 69367-203 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | REMEDYREPACK INC. | 70518-4309 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Proficient Rx LP | 71205-510 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Proficient Rx LP | 71205-981 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Bryant Ranch Prepack | 71335-1764 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Bryant Ranch Prepack | 71335-1767 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Asclemed USA, Inc. | 76420-802 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0570 |
| Butalbital, Acetaminophen, Caffeinebutalbital, acetaminophen, and caffeine | Butalbital 50 mg/1 + 2 more ingredients | TabletOral | HAWAII REPACK, INC. | 85534-0046 |