Over-the-counter drug · ANDA
Ibuprofen PM (Ibuprofen, diphenhydramine hcl) NDC 68016-057
Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Capsule, Liquid filled · Oral · Premier Value Alliance LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68016-057Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68016-0057Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68016-057-40 | 6801600574068016005740 | 1 BOTTLE in 1 CARTON (68016-057-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLEMarketed from Oct 25, 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 PM
- Generic name (nonproprietary)
- ibuprofen, diphenhydramine hcl
- Active ingredients
- Ibuprofen — 200 mg/1Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Capsule, Liquid filled
- Route
- Oral
- Labeler
- Premier Value Alliance LLCNDC labeler code 68016
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090397
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68016-057_21afce91-afbe-4b38-a8a5-8775148835e8SPL ID 21afce91-afbe-4b38-a8a5-8775148835e8SPL set ID 21afce91-afbe-4b38-a8a5-8775148835e8RxCUI 901814UNII WK2XYI10QM, TC2D6JAD40
- Pharmacologic class
- Histamine-1 Receptor Antagonist; 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
N468016005740followed by a unit qualifier and the quantityPackage 68016-0057-40. 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 ■ for relief of occasional sleeplessness when associated with minor aches and pains ■ helps you fall asleep and stay asleep
Excerpt only. Read the full label for complete information.
About NDC 68016-057
- What is NDC 68016-057?
- 68016-057 is the product NDC for Ibuprofen PM, Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 capsule, liquid filled, listed with the FDA by Premier Value Alliance LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibuprofen PM (Ibuprofen, Diphenhydramine HCl).
- What is the active ingredient?
- Ibuprofen, Diphenhydramine hydrochloride.
- Who is the labeler?
- Premier Value Alliance LLC, NDC labeler code 68016. 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 PM?
- 24 other product NDCs are listed under this name. See all Ibuprofen PM NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ibuprofen PM 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 PMibuprofen and diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Whole Foods Market, INC. | 42681-0061 | 42681-0061-01 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | HEB | 59640-020 | 59640-0020-15 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Diphenhydramine citrate 38 mg/1; Ibuprofen 200 mg/1 | Tablet, Film coatedOral | Safeway | 21130-623 | 21130-0623-76 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | WR Group, Inc. | 69607-1970 | 69607-1970-01 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | WALMART INC. (see also Equate) | 79903-186 | 79903-0186-2079903-0186-80 |
| Ibuprofen PMibuprofen and diphenhydramine citrate | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | KROGER COMPANY | 30142-278 | 30142-0278-80 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Safeway, Inc. | 21130-056 | 21130-0056-4021130-0056-80 |
| Ibuprofen PMdiphenhydramine citrate, ibuprofen | Ibuprofen 200 mg/1; Diphenhydramine citrate 38 mg/1 | Tablet, CoatedOral | Family Dollar (FAMILY WELLNESS) | 55319-197 | 55319-0197-2055319-0197-40 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | CVS Pharmacy | 69842-870 | 69842-0870-15 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | TOP CARE (Topco Associates LLC) | 36800-237 | 36800-0237-15 |
Other NDCs under ANDA 090397
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 and Diphenhydramine HClibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | VALU MERCHANDISERS COMPANY | 63941-682 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | WALGREEN COMPANY | 0363-0207 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | KROGER COMPANY | 30142-232 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | TOP CARE (Topco Associates LLC) | 36800-237 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | MEIJER DISTRIBUTION INC. | 41250-285 |
| Ibuprofen PMibuprofen and diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Whole Foods Market, INC. | 42681-0061 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Wal-Mart Stores, Inc. | 49035-670 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | HEB | 59640-020 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | CHAIN DRUG MARKETING ASSOCIATION INC. | 63868-829 |
| Ibuprofen PMibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | CVS Pharmacy | 69842-870 |
| Ibuprofen, Diphenhydramine HCl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | TARGET Corporation | 11673-225 |
| Ibuprofen, Diphenhydramine HCl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Rite Aid Corporation | 11822-0789 |
| Ibuprofen, Diphenhydramine HCl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Bionpharma Inc. | 69452-205 |
| pain relief pmibuprofen, diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Bionpharma Inc. | 69452-264 |
| pain relief pmibuprofen and diphenhydramine hcl | Ibuprofen 200 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Bionpharma Inc. | 69452-507 |