Prescription drug · ANDA
Diphenhydramine (Diphenhydramine hydrochloride) NDC 83634-781
Diphenhydramine hydrochloride 50 mg/mL · Injection, Solution · Intramuscular, Intravenous · Avenacy, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83634-781-01 | 8363407810183634078101 | 25 VIAL, SINGLE-DOSE in 1 CARTON (83634-781-01) / 1 mL in 1 VIAL, SINGLE-DOSE (83634-781-41)Marketed from Sep 1, 2025 |
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
- Generic name (nonproprietary)
- diphenhydramine hydrochloride
- Active ingredients
- Diphenhydramine hydrochloride — 50 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Avenacy, LLCNDC labeler code 83634
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205336
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 83634-781_908025cf-e126-4241-b794-47d2fd90078eSPL ID 908025cf-e126-4241-b794-47d2fd90078eSPL set ID 00f862aa-6917-45c7-b6aa-1bebb0a45e14RxCUI 1723740UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N483634078101followed by a unit qualifier and the quantityPackage 83634-0781-01. 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)
INDICATIONS AND USAGE Diphenhydramine hydrochloride injection, USP is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when the oral form is impractical. Antihistaminic For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. Motion Sickness For active treatment of motion sickness. Antiparkinsonism For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: pa…
Excerpt only. Read the full label for complete information.
About NDC 83634-781
- What is NDC 83634-781?
- 83634-781 is the product NDC for Diphenhydramine (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 50 mg/mL injection, solution, listed with the FDA by Avenacy, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diphenhydramine (Diphenhydramine hydrochloride).
- What is the active ingredient?
- Diphenhydramine hydrochloride.
- Who is the labeler?
- Avenacy, LLC, NDC labeler code 83634. 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?
- 6 other product NDCs are listed under this name. See all Diphenhydramine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diphenhydramine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diphenhydraminediphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4765 | 70518-4765-01 |
| Diphenhydraminediphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 65219-820 | 65219-0820-01 |
| Diphenhydraminediphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | Micro Labs Limited | 42571-337 | 42571-0337-5642571-0337-7842571-0337-87 |
| Diphenhydraminediphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | Micro Labs Limited | 42571-169 | 42571-0169-55 |
| Diphenhydraminediphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-090 | 57344-0090-0257344-0090-03 |
| Diphenhydraminediphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-664 | 63323-0664-16 |
Other NDCs under ANDA 205336
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/mL | InjectionIntramuscular, Intravenous | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-264 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4536 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | InjectionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7373 |