Prescription drug · ANDA
Diphenhydramine (Diphenhydramine hydrochloride) NDC 70518-4765
Diphenhydramine hydrochloride 50 mg/mL · Injection, Solution · Intramuscular, Intravenous · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4765-1 | 70518476501 | 25 VIAL in 1 CARTON (70518-4765-1) / 1 mL in 1 VIAL (70518-4765-0)Marketed from Sep 25, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205723
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70518-4765_5c8a86ee-4da0-0b52-e063-6294a90a5962SPL ID 5c8a86ee-4da0-0b52-e063-6294a90a5962
- 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
N470518476501followed by a unit qualifier and the quantityPackage 70518-4765-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70518-4765
- What is NDC 70518-4765?
- 70518-4765 is the product NDC for Diphenhydramine (diphenhydramine hydrochloride), Diphenhydramine hydrochloride 50 mg/mL injection, solution, listed with the FDA by REMEDYREPACK INC.. 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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?
- 7 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 | Avenacy, LLC | 83634-781 | 83634-0781-01 |
| 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 |
| Diphenhydraminediphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | Fresenius Kabi USA, LLC | 63323-664 | 63323-0664-01 |
Other NDCs under ANDA 205723
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 | Injection, SolutionIntramuscular, Intravenous | Armas Pharmaceuticals Inc. | 72485-101 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | ProPharma Distribution | 84549-101 |
| Diphenhydraminediphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | Micro Labs Limited | 42571-169 |
| Diphenhydraminediphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | Micro Labs Limited | 42571-337 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 50 mg/mL | Injection, SolutionIntramuscular, Intravenous | Medical Purchasing Solutions, LLC | 71872-7180 |