NDC codes

FDA NDC Directory
Product NDC (as listed)63629-2372Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-2372Add 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
63629-2372-16362923720163629237201100 CAPSULE in 1 BOTTLE (63629-2372-1)Marketed from Feb 22, 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

Generic name (nonproprietary)
butalbital, acetaminophen and caffeine
Active ingredients
Acetaminophen — 300 mg/1Caffeine — 40 mg/1Butalbital — 50 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207118
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 63629-2372_1c4a130a-f8e5-4115-934e-7df2165d8853SPL ID 1c4a130a-f8e5-4115-934e-7df2165d8853SPL set ID 03475828-eae2-49ed-a1c0-8074f35c712dRxCUI 889520UNII 362O9ITL9D, 3G6A5W338E, KHS0AZ4JVK
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

N463629237201 followed by a unit qualifier and the quantity

Package 63629-2372-01. 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)

INDICATIONS AND USAGE Butalbital, Acetaminophen, and Caffeine capsules, 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 63629-2372

What is NDC 63629-2372?
63629-2372 is the product NDC for Butalbital, Acetaminophen And Caffeine, Acetaminophen 300 mg/1 + 2 more ingredients capsule, listed with the FDA by Bryant Ranch Prepack. 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?
Acetaminophen, Caffeine, Butalbital.
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.

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 207118

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

FDA NDC Directory listings under ANDA 207118
ProductStrengthForm · routeLabelerProduct NDC
Butalbital, Acetaminophen And CaffeineAcetaminophen 300 mg/1 + 2 more ingredientsCapsuleOralSUNRISE PHARMACEUTICAL, INC11534-187
Butalbital, Acetaminophen And CaffeineAcetaminophen 300 mg/1 + 2 more ingredientsCapsuleOralBryant Ranch Prepack72162-1232

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in