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 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 LLCNDC labeler code 55758
- 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.
About NDC 55758-310
- What is NDC 55758-310?
- 55758-310 is the product NDC for Dolex Flex (ibuprofen), Ibuprofen 200 mg/1 capsule, liquid filled, listed with the FDA by Pharmadel LLC.
- What drug is associated with this NDC?
- Dolex Flex (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Pharmadel LLC, NDC labeler code 55758. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dolex Flex?
- 1 other product NDC are listed under this name. See all Dolex Flex NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Dolex Flex products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dolex Flexibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Pharmadel LLC | 55758-014 | 55758-0014-2055758-0014-99 |
Other NDCs under ANDA 206999
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Rite Aid Corporation | 11822-0894 |