Over-the-counter drug · ANDA
Ibuprofen mini NDC 53345-050
Ibuprofen 200 mg/1 · Capsule, Liquid filled · Oral · Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53345-050-01 | 53345005001 | 1 BAG in 1 BOX (53345-050-01) / 12000 CAPSULE, LIQUID FILLED in 1 BAGMarketed from Nov 20, 2018 |
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 mini
- Generic name (nonproprietary)
- ibuprofen mini
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Humanwell PuraCap Pharmaceutical (Wuhan) Co., LtdNDC labeler code 53345
- 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 53345-050_9524bc23-2aa5-4d58-8193-a972c52f1e04SPL ID 9524bc23-2aa5-4d58-8193-a972c52f1e04SPL set ID 787cda64-c03e-462e-9590-6f04b6860610RxCUI 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
N453345005001followed by a unit qualifier and the quantityPackage 53345-0050-01. 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.
About NDC 53345-050
- What is NDC 53345-050?
- 53345-050 is the product NDC for Ibuprofen mini, Ibuprofen 200 mg/1 capsule, liquid filled, listed with the FDA by Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen mini.
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd, NDC labeler code 53345. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ibuprofen mini?
- 1 other product NDC are listed under this name. See all Ibuprofen mini NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibuprofen mini products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ibuprofen Miniibuprofen mini 200 mg | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | TARGET CORPORATION | 11673-683 | 11673-0683-3211673-0683-6611673-0683-80 |
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 | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | 53345-039 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd | 53345-039 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Sam's West, Inc | 68196-745 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd | 53345-059 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Sam's West, Inc. | 68196-981 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Best Choice (Valu Merchandisers Company) | 63941-745 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Topco Associates LLC | 36800-440 |
| Ibuprofen minisibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-953 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | PuraCap Pharmaceutical LLC | 51013-103 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | PuraCap Pharmaceutical LLC | 51013-421 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | PuraCap Pharmaceutical LLC | 51013-405 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | PuraCap Pharmaceutical LLC | 51013-410 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | PuraCap Pharmaceutical LLC | 51013-422 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | PURACAP PHARMACEUTICAL LLC | 51013-429 |
| Ibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | The Kroger Co. | 30142-745 |
| 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 minisibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | WR Group, Inc. | 69607-8438 |
| Ibuprofen minisibuprofen | Ibuprofen 200 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-0743 |
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