Over-the-counter drug · ANDA
Dolex Flex (ibuprofen) NDC 55758-310
Ibuprofen 200 mg/1 · Capsule, Liquid filled · Oral · Pharmadel LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)55758-310Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55758-0310Add the package segment from the table below.
Product information
- Brand name (proprietary)
- Dolex Flex
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Pharmadel LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206999
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 55758-310_0542f88c-b29d-d32c-e063-6294a90ab9eeSPL ID 0542f88c-b29d-d32c-e063-6294a90ab9eeSPL set ID 822d9def-504c-9beb-e053-2991aa0a280eRxCUI 310964UNII WK2XYI10QM
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses Temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache backache the common cold menstrual cramps temporarily reduces fever
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206999
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.