NDC 37808-057OTC monographFDA ANDA · ANDA075217

Ibuprofen infants

Active substance: Ibuprofen

FDA labeler: H E B

9 formulations • 11 package configurations
All 20 registered NDCs — click to copy
In one line

Ibuprofen infants (Ibuprofen) NDC 37808-057 converts to 37808-0057-05 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: 37808-057
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
37808-0057-05
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 ibuprofen infants, with 10-digit and 11-digit NDC formats
Formulation / rolePackage NDCProduct NDC11-digit HIPAAPackaging detailCopy
50 mg/1.25mL37808-057-0537808-05737808-0057-051 BOTTLE in 1 CARTON (37808-057-05) / 15 mL in 1 BOTTLE
50 mg/1.25mL53943-637-0953943-63753943-0637-091 BOTTLE in 1 CARTON (53943-637-09) / 30 mL in 1 BOTTLE
50 mg/1.25mL0113-0057-050113-005700113-0057-051 BOTTLE in 1 CARTON (0113-0057-05) / 15 mL in 1 BOTTLE
50 mg/1.25mL42507-057-0542507-05742507-0057-051 BOTTLE in 1 CARTON (42507-057-05) / 15 mL in 1 BOTTLE (42507-057-00)
Inner component42507-057-0042507-05742507-0057-00Inner component of kit (42507-057-05)
50 mg/1.25mL69256-687-0969256-68769256-0687-091 BOTTLE in 1 CARTON (69256-687-09) / 30 mL in 1 BOTTLE
50 mg/1.25mL53041-637-0953041-63753041-0637-091 BOTTLE in 1 CARTON (53041-637-09) / 30 mL in 1 BOTTLE
50 mg/1.25mL49035-635-0949035-63549035-0635-091 BOTTLE in 1 CARTON (49035-635-09) / 30 mL in 1 BOTTLE
50 mg/1.25mL83324-005-3083324-00583324-0005-301 BOTTLE in 1 CARTON (83324-005-30) / 30 mL in 1 BOTTLE
50 mg/1.25mL51672-2146-351672-214651672-2146-031 BOTTLE in 1 CARTON (51672-2146-3) / 30 mL in 1 BOTTLE
50 mg/1.25mL51672-2146-551672-214651672-2146-051 BOTTLE in 1 CARTON (51672-2146-5) / 15 mL in 1 BOTTLE
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
USE(S) temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
DIRECTIONS this product does not contain directions or complete warnings for adult use do not give more than directed shake well before using find right dose on chart below. If possible, use weight to dose; otherwise use age. mL=milliliter measure with dosing device provided. Do not use any other dosing device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart WEIGHT (lb) AGE (mos) DOSE (mL) under 6 mos ask a doctor 12-17 lbs 6-11 mos 1.25 mL 18-23 lbs 12-23 years 1.875 mL
WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives facial swelling asthma (wheezing) shock skin reddening rash blisters If an allergic reaction occurs, stop use and seek medical help right away. Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you child: has had stomach ulcers or bleeding problems takes a blood thinning (anticoagulant) or steroid drug takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) takes more or for a longer time than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.
Pharmacologic class

Anti-Inflammatory Agents

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

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