Over-the-counter drug · OTC MONOGRAPH DRUG
Pharbedryl (Diphenhydramine hcl) NDC 16103-348
Diphenhydramine hydrochloride 25 mg/1 · Capsule · Oral · Pharbest Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16103-348-08 | 1610303480816103034808 | 1 BOTTLE, PLASTIC in 1 CARTON (16103-348-08) / 100 CAPSULE in 1 BOTTLE, PLASTICMarketed from Feb 1, 2016 | |
| 16103-348-11 | 1610303481116103034811 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (16103-348-11)Marketed from Feb 1, 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)
- Pharbedryl
- Generic name (nonproprietary)
- diphenhydramine hcl
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Pharbest Pharmaceuticals, Inc.NDC labeler code 16103
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 010
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 16103-348_1c298805-036e-4cd1-87cc-1d2e413043b8SPL ID 1c298805-036e-4cd1-87cc-1d2e413043b8SPL set ID 070e556b-e083-452f-8a7c-aca92470dd61RxCUI 1049909UNII TC2D6JAD40
- Pharmacologic class
- Histamine-1 Receptor Antagonist
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
N416103034808followed by a unit qualifier and the quantityPackage 16103-0348-08. 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 these symptoms due to hay fever or other respiratory allergies: sneezing itching of the nose or throat runny nose itchy, watery eyes Temporarily relieves these symptoms due to common cold: runny nose sneezing
Excerpt only. Read the full label for complete information.
About NDC 16103-348
- What is NDC 16103-348?
- 16103-348 is the product NDC for Pharbedryl (diphenhydramine hcl), Diphenhydramine hydrochloride 25 mg/1 capsule, listed with the FDA by Pharbest Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pharbedryl (Diphenhydramine HCl).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Pharbest Pharmaceuticals, Inc., NDC labeler code 16103. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pharbedryl?
- 2 other product NDCs are listed under this name. See all Pharbedryl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pharbedryl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pharbedryldiphenhydramine hcl 50mg | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Ulai Health LLC | 73057-347 | 73057-0347-0873057-0347-11 |
| Pharbedryldiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Pharbest Pharmaceuticals, Inc. | 16103-347 | 16103-0347-0816103-0347-11 |
Other NDCs under M 010
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 |
|---|---|---|---|---|
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Softgel Healthcare Pvt Ltd | 35916-0472 |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Chain Drug Marketing Association | 63868-611 |
| Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Shield Pharmaceuticals Corp | 83059-0075 |
| Wal Som Nighttime Sleep Aid Nighttimediphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Walgreens | 0363-0860 |
| Nighttime Sleep Aiddiphenhydramine hcl 25 mg | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Health Pharma USA LLC | 71679-110 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | QUALITY CHOICE (Chain Drug Marketing Association) | 83324-151 |
| Nighttime Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | H E B | 37808-186 |
| Nighttime Sleep Aid | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | Allegiant Health | 69168-486 |
| Sleep Aid Night Timediphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | DOLGENCORP, LLC | 55910-687 |
| Sleep Aid | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Allegiant Health | 69168-917 |
| Nighttime Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services LLC | 70677-1128 |
| TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Topco Associates LLC | 76162-438 |
| Sleep Aid Maximum Strengthdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | H E B | 37808-860 |
| Nighttime Sleep Aid Alcohol Freediphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | Wal-Mart Stores Inc | 49035-330 |
| Somnitabsdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | HARRIS TEETER | 72036-019 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Amerisource Bergen | 46122-651 |
| Vicks ZzzQuil Nighttime Sleep-Aiddiphenhydramine hydrochloride | — | Kit | The Procter & Gamble Manufacturing Company | 84126-306 |
| Nighttime SleepAiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | AMERIFOODS TRADING COMPANY | 61504-091 |
| Pharbedryldiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Pharbest Pharmaceuticals, Inc. | 16103-347 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 110, LLC. DBA Leader | 70000-0244 |
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