Over-the-counter drug · ANDA
Dolex Flex (Ibuprofen) NDC 55758-014
Ibuprofen 200 mg/1 · Capsule, Liquid filled · Oral · Pharmadel LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55758-014-20 | 5575800142055758001420 | 1 BOTTLE in 1 CARTON (55758-014-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Sep 7, 2023 | |
| 55758-014-99 | 5575800149955758001499 | 50 PACKET in 1 CARTON (55758-014-99) / 2 CAPSULE, LIQUID FILLED in 1 PACKET (55758-014-02)Marketed from Nov 1, 2023 |
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)
- 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 078682
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 55758-014_4d7a9ecd-d071-a923-e063-6394a90ad412SPL ID 4d7a9ecd-d071-a923-e063-6394a90ad412SPL set ID 0543420d-a250-065d-e063-6294a90a005eRxCUI 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.
- NDC on a medical claim
N455758001420followed by a unit qualifier and the quantityPackage 55758-0014-20. 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 .
Indications (excerpt from the label)
Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain from arthritis and to reduce fever
Excerpt only. Read the full label for complete information.
About NDC 55758-014
- What is NDC 55758-014?
- 55758-014 is the product NDC for Dolex Flex (ibuprofen), Ibuprofen 200 mg/1 capsule, liquid filled, listed with the FDA by Pharmadel LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- 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 | 55758-310 | — |
Other NDCs under ANDA 078682
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 | BJWC | 68391-212 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | MEIJER DISTRIBUTION INC. | 41250-286 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | MEIJER DISTRIBUTION INC. | 41250-292 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | MEIJER DISTRIBUTION INC. | 41250-293 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Bi-Mart | 37835-588 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Whole Foods Market, INC. | 42681-0052 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Rite Aid Corporation | 11822-0589 |
| Ibuprofen, Solubilized 24/7 Life by 7-Elevenibuprofen capsule, liquid filled | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Lil' Drug Store products, Inc. | 66715-5646 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | HEB | 37808-609 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | TOP CARE (Topco Associates LLC) | 36800-193 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | WALGREEN COMPANY | 0363-0221 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Costco Wholesale | 63981-598 |
| Motrin IB Migraineibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Kenvue Brands LLC | 50580-120 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Cardinal Health (Leader) 70000 | 70000-0571 |
| Ibuprofen 200ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | WALGREEN COMPANY | 0363-0222 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | TOP CARE (Topco Associates LLC) | 36800-221 |
| Ibuprofen Migraineibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | CVS Pharmacy | 69842-892 |
| Dye-Free Ibuprofen 200ibuprofen | Ibuprofen 200 mg/1201 | Capsule, Liquid filledOral | WALGREEN COMPANY | 0363-0225 |
| Pain Reliefibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Albertsons Companies | 21130-220 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | H E B | 37808-699 |
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