NDC codes

FDA NDC Directory
Product NDC (as listed)51991-074Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51991-0074Add 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
51991-074-015199100740151991007401100 CAPSULE in 1 BOTTLE, PLASTIC (51991-074-01)Marketed from May 1, 2009
51991-074-055199100740551991007405500 CAPSULE in 1 BOTTLE, PLASTIC (51991-074-05)Marketed from May 1, 2009

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)
Ascomp with Codeine
Generic name (nonproprietary)
butalbital, aspirin, caffeine and codeine phosphate
Active ingredients
Butalbital — 50 mg/1Aspirin — 325 mg/1Caffeine — 40 mg/1Codeine phosphate — 30 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Breckenridge Pharmaceutical, Inc.NDC labeler code 51991
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075231
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)Full Opioid Agonists (Mechanism)Xanthines (Chemical structure)
Identifiers
Product ID 51991-074_a41a61f0-e530-4fb5-8198-bdc866219e33SPL ID a41a61f0-e530-4fb5-8198-bdc866219e33SPL set ID 243a6aea-0f48-42a9-a85e-ff247ab94336RxCUI 994237, 994239UNII KHS0AZ4JVK, R16CO5Y76E, 3G6A5W338E, GSL05Y1MN6
Pharmacologic class
Barbiturate; Central Nervous System Stimulant; Methylxanthine; Nonsteroidal Anti-inflammatory Drug; Opioid Agonist; 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

N451991007401 followed by a unit qualifier and the quantity

Package 51991-0074-01. 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)

ASCOMP with Codeine is indicated for the management of the symptom complex of tension (or muscle contraction) headache, when non-opioid analgesic and alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ] , reserve opioid analgesics, including ASCOMP with Codeine, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ASCOMP with Codeine should not be used for an extended period of time unles…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51991-074

What is NDC 51991-074?
51991-074 is the product NDC for Ascomp with Codeine, Butalbital 50 mg/1 + 3 more ingredients capsule, listed with the FDA by Breckenridge Pharmaceutical, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ascomp with Codeine (Butalbital, Aspirin, Caffeine and Codeine Phosphate).
What is the active ingredient?
Butalbital, Aspirin, Caffeine, Codeine phosphate.
Who is the labeler?
Breckenridge Pharmaceutical, Inc., NDC labeler code 51991. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ascomp with Codeine?
1 other product NDC are listed under this name. See all Ascomp with Codeine 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 Ascomp with Codeine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ascomp with Codeinebutalbital, aspirin, cafeine, and codeine phosphateButalbital 50 mg/1 + 3 more ingredientsCapsuleOralLGM PHARMA SOLUTIONS, LLC79739-609479739-6094-01

Other NDCs under ANDA 075231

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

FDA NDC Directory listings under ANDA 075231
ProductStrengthForm · routeLabelerProduct NDC
Ascomp with Codeinebutalbital, aspirin, cafeine, and codeine phosphateButalbital 50 mg/1 + 3 more ingredientsCapsuleOralLGM PHARMA SOLUTIONS, LLC79739-6094
Butalbital, Aspirin, Caffeine And Codeine PhosphateButalbital 50 mg/1 + 3 more ingredientsCapsuleOralBryant Ranch Prepack63629-2952

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