NDC 49483-387OTC monographFDA OTC MONOGRAPH FINAL · part343

Aspirin low dose enteric coated

Active substance: Aspirin

FDA labeler: Time-Cap Labs, Inc

2 formulations • 4 package configurations
All 6 registered NDCs — click to copy
In one line

Aspirin low dose enteric coated (Aspirin) NDC 49483-387 converts to 49483-0387-00 for billing. It is dispensed by a pharmacy and billed directly on the NDC — no HCPCS J-code is required.

openFDA Live Registry SyncHIPAA 5-4-2 StandardCMS Level II Crosswalk
Listing: 49483-387
Billing & reimbursement crosswalk

NDC • HCPCS Level II • CPT administration

Reimbursement channel
NDC direct
Oral / Topical formulation billed directly via 11-Digit NDC (No HCPCS J-Code required).
Standard pharmacy claim — no J-Code required
11-digit HIPAA NDC
49483-0387-00
Zero-padded 5-4-2 format
Standard conversion
CPT administration code
Self-Administered (Oral)
Dispensed via retail/mail pharmacy. No clinical administration procedure (CPT) required.
UB-04 revenue code
Rev 0250
0250 (General Pharmacy)
Qualifier: UN
Complete drug registry

All registered strengths & packaging

Every registered strength and package for aspirin low dose enteric coated, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
81 mg/149483-387-0049483-38749483-0387-00100000 TABLET, COATED in 1 CARTON (49483-387-00)
81 mg/149483-387-1049483-38749483-0387-101000 TABLET, COATED in 1 BOTTLE, PLASTIC (49483-387-10)
81 mg/149483-387-1249483-38749483-0387-12120 TABLET, COATED in 1 BOTTLE, PLASTIC (49483-387-12)
81 mg/149483-390-0049483-39049483-0390-00100000 TABLET in 1 CARTON (49483-390-00)
FDA drug label

Prescribing information

Taken from the manufacturer's FDA Structured Product Labeling submission. This is the label as filed, not a summary.

3 Label Sections
Uses: temporarily relieves minor aches and pains: for other uses, see your doctor, but do not use for more than 10 days without consulting your doctor because serious side effects may occur.
Directions: drink a full glass of water with each dose; adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor Children under 12 years - consult a doctor
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives, facial swelling, shock, asthma(wheezing Stomach bleeding warning: This product contains an NSAID which may cause severe stomach bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed.
Pharmacologic class

Anti-Inflammatory Agents

Every other National Drug Code registered in the same established class.

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