What is NDC 46672-053?

46672-053 is the product NDC for butalbital, acetaminophen and caffeine, Butalbital 50 mg/1 + 2 more ingredients tablet, listed with the FDA by Mikart, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Butalbital, Acetaminophen, Caffeine.

Mikart, LLC, NDC labeler code 46672. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

butalbital, acetaminophen and caffeine NDC 46672-053

NDC codes

FDA NDC Directory

Product NDC (as listed)46672-053Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46672-0053Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
46672-053-10	4667200531046672005310	100 TABLET in 1 BOTTLE, PLASTIC (46672-053-10)Marketed from Jan 21, 1987
46672-053-50	4667200535046672005350	500 TABLET in 1 BOTTLE, PLASTIC (46672-053-50)Marketed from Jan 21, 1987

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 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: Mikart, LLCNDC labeler code 46672
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 089175
Marketing start: Jan 21, 1987
Listing expires: Dec 31, 2026
DEA schedule: CIII
Other FDA classes: Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Xanthines (Chemical structure)
Identifiers: Product ID 46672-053_0e845d26-e49d-1fad-e063-6294a90ad864SPL ID 0e845d26-e49d-1fad-e063-6294a90ad864SPL set ID a26775c2-cafb-4b13-99ac-d4e8248265fbRxCUI 238154UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338EUPC 0346672053105
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

N446672005310 followed by a unit qualifier and the quantity

Package 46672-0053-10. 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 Jan 9, 2024. 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.

Full label on DailyMed (opens in a new tab)

About NDC 46672-053

What is NDC 46672-053?: 46672-053 is the product NDC for butalbital, acetaminophen and caffeine, Butalbital 50 mg/1 + 2 more ingredients tablet, listed with the FDA by Mikart, LLC. It has 2 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?: Mikart, LLC, NDC labeler code 46672. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other butalbital, acetaminophen and caffeine NDCs
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

All 51 butalbital, acetaminophen and caffeine NDCs

Other NDCs under ANDA 089175

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 089175
Product	Strength	Form · route	Labeler	Product NDC
Butalbital, Acetaminophen And Caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Chartwell RX, LLC	62135-751
butalbital, acetaminophen and caffeine	Butalbital 50 mg/1 + 2 more ingredients	TabletOral	Proficient Rx LP	63187-520