Prescription drug · ANDA
Diphenhydramine hydrochloride NDC 31722-601
Diphenhydramine hydrochloride 25 mg/10mL · Solution · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-601-31 | 31722060131 | 10 CARTON in 1 BOX (31722-601-31) / 10 CUP, UNIT-DOSE in 1 CARTON / 10 mL in 1 CUP, UNIT-DOSEMarketed from Jun 17, 2026 |
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)
- Diphenhydramine hydrochloride
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 25 mg/10mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 219470
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 31722-601_55c4288b-2cc9-7cb6-e063-6294a90a8ff8SPL ID 55c4288b-2cc9-7cb6-e063-6294a90a8ff8SPL set ID f808ee14-fccf-4abe-b53a-a40b0b3bba03RxCUI 1049906UNII TC2D6JAD40UPC 0331722601313, 0331722601337
- 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
N431722060131followed by a unit qualifier and the quantityPackage 31722-0601-31. 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)
INDICATIONS AND USAGE Diphenhydramine hydrochloride in the oral form is effective for the following indications: Antihistaminic For allergic conjunctivitis due to foods; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; amelioration of allergic reactions to blood or plasma; dermatographism; as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. Motion Sickness For active and prophylactic treatment of motion sickness. Antiparkinsonism For parkinsonism (including drug-induced) in the elderly unable to tolerate more potent agents; mild cases of parkinsonism (including drug-induc…
Excerpt only. Read the full label for complete information.
About NDC 31722-601
- What is NDC 31722-601?
- 31722-601 is the product NDC for Diphenhydramine hydrochloride, Diphenhydramine hydrochloride 25 mg/10mL solution, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diphenhydramine hydrochloride.
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diphenhydramine hydrochloride?
- 81 other product NDCs are listed under this name. See all Diphenhydramine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diphenhydramine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-1589 | 55154-1589-00 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Health Pharma USA LLC | 71679-308 | 71679-0308-00 |
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 12.5 mg/5mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-600 | 31722-0600-1131722-0600-31 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4536 | 70518-4536-00 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-263 | 23155-0263-31 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Micro Labs Limited | 42571-511 | 42571-0511-56 |
| Diphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4455 | 70518-4455-00 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Prodose, Inc. | 68210-5057 | 68210-5057-01 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7373 | 71872-7373-01 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-264 | 23155-0264-41 |
Other NDCs under ANDA 219470
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 12.5 mg/5mL | SolutionOral | Camber Pharmaceuticals, Inc. | 31722-600 |