Over-the-counter drug · ANDA
Fast Pain Relief (Ibuprofen) NDC 69517-111
Ibuprofen 200 mg/1 · Tablet, Coated · Oral · HealthLife of USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69517-111-02 | 6951701110269517011102 | 2 POUCH in 1 POUCH (69517-111-02) / 2 TABLET, COATED in 1 POUCHMarketed from Apr 6, 2016 | |
| 69517-111-10 | 6951701111069517011110 | 1000 BOTTLE in 1 BOTTLE (69517-111-10) / 500 BOTTLE in 1 BOTTLE (69517-111-05) / 30 CARTON in 1 BOTTLE (69517-111-30) / 1 TABLET, COATED in 1 CARTONMarketed from Apr 6, 2016 | |
| 69517-111-25 | 6951701112569517011125 | 25 POUCH in 1 CARTON (69517-111-25) / 2 TABLET, COATED in 1 POUCHMarketed from Apr 6, 2016 | |
| 69517-111-50 | 6951701115069517011150 | 50 POUCH in 1 CARTON (69517-111-50) / 2 TABLET, COATED in 1 POUCHMarketed from Apr 6, 2016 |
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)
- Fast Pain Relief
- Generic name (nonproprietary)
- ibuprofen
- Active ingredients
- Ibuprofen — 200 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- HealthLife of USA LLCNDC labeler code 69517
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079174
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 69517-111_8e733e89-3460-49b9-a157-4f2f91bb14ccSPL ID 8e733e89-3460-49b9-a157-4f2f91bb14ccSPL set ID a3fcd34a-6aa9-477c-bbfb-2f6b36e06b65RxCUI 310965UNII 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
N469517011102followed by a unit qualifier and the quantityPackage 69517-0111-02. 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 69517-111
- What is NDC 69517-111?
- 69517-111 is the product NDC for Fast Pain Relief (ibuprofen), Ibuprofen 200 mg/1 tablet, coated, listed with the FDA by HealthLife of USA LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fast Pain Relief (Ibuprofen).
- What is the active ingredient?
- Ibuprofen.
- Who is the labeler?
- HealthLife of USA LLC, NDC labeler code 69517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fast Pain Relief?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 079174
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 |
|---|---|---|---|---|
| Dover Addaprinibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Unifirst First Aid Corporation | 47682-714 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | BETTER LIVING BRANDS LLC. | 21130-396 |
| Medique Iprinibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Unifirst First Aid Corporation | 47682-700 |
| Medi-First Plus Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Unifirst First Aid Corporation | 47682-709 |
| Pain Relief - Ibuprofen 200 mgibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Health Pharma USA LLC | 71679-111 |
| Green Guard Ibuprofen Reliefibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Unifirst First Aid | 47682-710 |
| Medi-First Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Unifirst First Aid Corporation | 47682-718 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-109 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-110 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules USA, Inc. | 69848-011 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Granules USA, Inc. | 69848-012 |
| Direct Safety Ibuprofenibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | Conney Safety Products, LLC | 61245-084 |
| Lil Drug Store Ibuprofenibuprofen | Ibuprofen 200 mg/1 | TabletOral | Lil Drug Store Products, Inc | 66715-6839 |
| Medique at Home Iprinibuprofen | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Unifirst First Aid Corporation | 47682-783 |
| Physicians Care Ibuprofenibuprofen 200mg | Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Acme United Corporation | 0924-0076 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AMERIFOODS TRADING COMPANY | 61504-109 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | RETAIL BUSINESS SERVICES,LLC. | 72476-365 |
| Ibuprofen | Ibuprofen 200 mg/1 | Tablet, CoatedOral | AMERIFOODS TRADING COMPANY | 61504-110 |
| Ibuprofen | Ibuprofen 200 mg/1 | TabletOral | Retail Business Services, LLC | 72476-366 |
| Ibuwin Forteibuprofen | Ibuprofen 200 mg/1 | TabletOral | OPMX LLC | 69729-157 |
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