NDC codes

FDA NDC Directory
Product NDC (as listed)55154-3356Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-3356Add 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 NDC11-digit (billing)PackageCopy
55154-3356-0551543356005515433560010 BLISTER PACK in 1 BAG (55154-3356-0) / 1 TABLET in 1 BLISTER PACKMarketed from Sep 13, 2012

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

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
Cardinal Health 107, LLCNDC labeler code 55154
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 55154-3356_847db420-0b19-4cd2-9db3-acce0f4281dbSPL ID 847db420-0b19-4cd2-9db3-acce0f4281dbSPL set ID ab70f3dc-708e-4455-99ff-a2b9fe2d71a3RxCUI 238154UNII KHS0AZ4JVK, 362O9ITL9D, 3G6A5W338EUPC 0055154335607
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

N455154335600 followed by a unit qualifier and the quantity

Package 55154-3356-00. 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.

Full label on DailyMed (opens in a new tab)

About NDC 55154-3356

What is NDC 55154-3356?
55154-3356 is the product NDC for Butalbital, Acetaminophen, and Caffeine, Butalbital 50 mg/1 + 2 more ingredients tablet, listed with the FDA by Cardinal Health 107, LLC. It has 1 package NDC, 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?
Cardinal Health 107, LLC, NDC labeler code 55154. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Butalbital, Acetaminophen and CaffeineButalbital 50 mg/1 + 2 more ingredientsTabletOralPreferred Pharmaceuticals Inc.68788-412668788-4126-0268788-4126-03
Butalbital, Acetaminophen And CaffeineButalbital 50 mg/1 + 2 more ingredientsTabletOralREMEDYREPACK INC.70518-460170518-4601-0070518-4601-0170518-4601-02
Butalbital, Acetaminophen And CaffeineButalbital 50 mg/1 + 2 more ingredientsCapsuleOralAmici Pharma, Inc.69292-30569292-0305-01
Butalbital, Acetaminophen And CaffeineButalbital 50 mg/1 + 2 more ingredientsTabletOralAdvanced Rx of Tennessee, LLC80425-056780425-0567-0180425-0567-0280425-0567-03
Butalbital, Acetaminophen and Caffeinebutalbital, acetaminophen, and caffeineButalbital 50 mg/15mL + 2 more ingredientsSolutionOralGenus Lifesciences Inc.64950-29064950-0290-16
Butalbital, Acetaminophen And CaffeineButalbital 50 mg/1 + 2 more ingredientsCapsuleOralAdvanced Rx of Tennessee, LLC80425-049780425-0497-01
Butalbital, Acetaminophen And CaffeineButalbital 50 mg/1 + 2 more ingredientsTabletOralPreferred Pharmaceuticals Inc.68788-879468788-8794-0268788-8794-03
butalbital, acetaminophen and caffeineButalbital 50 mg/1 + 2 more ingredientsCapsuleOralDr. Reddy's Labratories Inc.75907-00975907-0009-01
Butalbital, Acetaminophen And CaffeineButalbital 50 mg/1 + 2 more ingredientsTabletOralQUAGEN PHARMACEUTICALS LLC70752-14270752-0142-1070752-0142-14
Butalbital, Acetaminophen And CaffeineButalbital 50 mg/1 + 2 more ingredientsCapsuleOralQUAGEN PHARMACEUTICALS LLC70752-14470752-0144-1070752-0144-14

All 51 Butalbital, Acetaminophen, and Caffeine NDCs

Other NDCs under ANDA 200243

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

FDA NDC Directory listings under ANDA 200243
ProductStrengthForm · routeLabelerProduct NDC
Butalbital, Acetaminophen, and CaffeineButalbital 50 mg/1 + 2 more ingredientsTabletOralBryant Ranch Prepack63629-8392
Butalbital, Acetaminophen, and CaffeineAcetaminophen 325 mg/1 + 2 more ingredientsTabletOralNuCare Pharmaceuticals, Inc.68071-3249
Butalbital, Acetaminophen, and CaffeineButalbital 50 mg/1 + 2 more ingredientsTabletOralREMEDYREPACK INC.70518-1134
Butalbital, Acetaminophen, and CaffeineButalbital 50 mg/1 + 2 more ingredientsTabletOralLannett Company, Inc.0527-1695
Butal/APAP/CaffButalbital 50 mg/1 + 2 more ingredientsTabletOralDirect_Rx72189-441
Butalbital, Acetaminophen, and CaffeineButalbital 50 mg/1 + 2 more ingredientsTabletOralMajor Pharmaceuticals0904-6938
Butalbital, Acetaminophen, and CaffeineButalbital 50 mg/1 + 2 more ingredientsTabletOralProficient Rx LP63187-933

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