NDC codes

FDA NDC Directory
Product NDC (as listed)0527-1552Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00527-1552Add 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
0527-1552-0100527155201100 CAPSULE in 1 BOTTLE (0527-1552-01)Marketed from Oct 11, 1985

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, aspirin, and caffeine
Generic name (nonproprietary)
butalbital, aspirin, and caffeine
Active ingredients
Butalbital — 50 mg/1Aspirin — 325 mg/1Caffeine — 40 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Lannett Company, Inc.NDC labeler code 0527
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 086996
Marketing start
Listing expires
DEA schedule
CIII
Other FDA classes
Non-Steroidal (Chemical structure)Barbiturates (Chemical structure)Central Nervous System Stimulation (Physiologic effect)Cyclooxygenase Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)Decreased Prostaglandin Production (Physiologic effect)Xanthines (Chemical structure)
Identifiers
Product ID 0527-1552_6b42bae1-bbc0-4337-8836-592b1beb7330SPL ID 6b42bae1-bbc0-4337-8836-592b1beb7330SPL set ID ba60b130-33cd-4db9-92a7-2cab8ded0737RxCUI 238134UNII KHS0AZ4JVK, R16CO5Y76E, 3G6A5W338EUPC 0305271552013
Pharmacologic class
Barbiturate; Central Nervous System Stimulant; Methylxanthine; Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor

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

N400527155201 followed by a unit qualifier and the quantity

Package 00527-1552-01. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Butalbital, aspirin, and caffeine capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, aspirin, and caffeine capsules 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 0527-1552

What is NDC 0527-1552?
0527-1552 is the product NDC for Butalbital, aspirin, and caffeine, Butalbital 50 mg/1 + 2 more ingredients capsule, listed with the FDA by Lannett Company, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Butalbital, aspirin, and caffeine.
What is the active ingredient?
Butalbital, Aspirin, Caffeine.
Who is the labeler?
Lannett Company, Inc., NDC labeler code 0527. 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, aspirin, and caffeine?
4 other product NDCs are listed under this name. See all Butalbital, aspirin, 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, aspirin, and caffeine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Butalbital, Aspirin, And CaffeineButalbital 50 mg/1 + 2 more ingredientsCapsuleOralWestminster Pharmaceuticals, LLC69367-41669367-0416-01
Butalbital, aspirin, and caffeineButalbital 50 mg/1 + 2 more ingredientsCapsuleOralSandoz Inc0781-227000781-2270-01
Butalbital, Aspirin, and CaffeineButalbital 50 mg/1 + 2 more ingredientsCapsuleOralLGM PHARMA SOLUTIONS, LLC79739-719279739-7192-0179739-7192-05
butalbital, aspirin, and caffeineButalbital 50 mg/1 + 2 more ingredientsCapsuleOralChartwell RX, LLC62135-43362135-0433-90

Other NDCs under ANDA 086996

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

FDA NDC Directory listings under ANDA 086996
ProductStrengthForm · routeLabelerProduct NDC
Butalbital, aspirin, and caffeineButalbital 50 mg/1 + 2 more ingredientsCapsuleOralSandoz Inc0781-2270
butalbital, aspirin, and caffeineButalbital 50 mg/1 + 2 more ingredientsCapsuleOralChartwell RX, LLC62135-433

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