Over-the-counter drug · ANDA
Ibuprofen NDC 53345-059
Ibuprofen 200 mg/1 · Capsule, Liquid filled · Oral · Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53345-059-01 | 53345005901 | 1 BAG in 1 CARTON (53345-059-01) / 12000 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Dec 28, 2025 |
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)
- Ibuprofen
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206568
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 53345-059_46a9387e-0883-f8cd-e063-6294a90af8c4SPL ID 46a9387e-0883-f8cd-e063-6294a90af8c4SPL set ID 46a9424c-fd7d-f88b-e063-6294a90abcebRxCUI 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
N453345005901followed by a unit qualifier and the quantityPackage 53345-0059-01. 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 of arthritis ♦ temporarily reduces fever
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206568
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 | CVS Pharmacy | 69842-745 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | PuraCap Pharmaceutical LLC | 51013-103 |
| Ibuprofen minisibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-953 |
| Ibuprofen minisibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | The Kroger Co. | 30142-743 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | The Kroger Co. | 30142-745 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | PuraCap Pharmaceutical LLC | 51013-410 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | PuraCap Pharmaceutical LLC | 51013-405 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | PuraCap Pharmaceutical LLC | 51013-421 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | PuraCap Pharmaceutical LLC | 51013-422 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | PURACAP PHARMACEUTICAL LLC | 51013-429 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | AAFES/Your Military Exchanges | 55301-745 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Rugby Laboratories, Inc. | 0536-1147 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Care One (American Sales Company) | 41520-745 |
| Ibuprofen Minisibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Family Dollar (FAMILY WELLNESS) | 55319-971 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Care One (Retail Business Services, LLC.) | 72476-745 |
| Ibuprofen minisibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Care One (Retail Business Services, LLC.) | 72476-843 |
| Ibuprofen minisibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Strategic Sourcing Services LLC | 70677-1113 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Strategic Sourcing Services LLC | 70677-1114 |
| Ibuprofen minisibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | WR Group, Inc. | 69607-8438 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Chain Drug Consortium, LLC | 68016-813 |
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