Prescription drug · ANDA
Diazepam NDC 70710-2080
Diazepam 20 mg/4mL · Gel · Rectal · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-2080-2 | 70710208002 | 2 SYRINGE, PLASTIC in 1 PACKAGE (70710-2080-2) / 4 mL in 1 SYRINGE, PLASTICMarketed from Dec 15, 2025 |
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)
- Diazepam
- Generic name (nonproprietary)
- diazepam
- Active ingredients
- Diazepam — 20 mg/4mL
- Dosage form
- Gel
- Route
- Rectal
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217468
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 70710-2080_ef34ecf3-de17-4493-82ef-857565ac4340SPL ID ef34ecf3-de17-4493-82ef-857565ac4340SPL set ID 652714c7-25c4-4d05-979d-8eee3b6f2f4dRxCUI 801957, 801961, 801966UNII Q3JTX2Q7TU
- Pharmacologic class
- Benzodiazepine
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.
- NDC on a medical claim
N470710208002followed by a unit qualifier and the quantityPackage 70710-2080-02. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Diazepam rectal gel is intended for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older.
Excerpt only. Read the full label for complete information.
About NDC 70710-2080
- What is NDC 70710-2080?
- 70710-2080 is the product NDC for Diazepam, Diazepam 20 mg/4mL gel, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diazepam.
- What is the active ingredient?
- Diazepam.
- Who is the labeler?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diazepam?
- 116 other product NDCs are listed under this name. See all Diazepam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diazepam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diazepam | Diazepam 5 mg/mL | InjectionIntramuscular, Intravenous | Civica, Inc. | 72572-175 | 72572-0175-10 |
| Diazepam | Diazepam 10 mg/2mL | Injection, SolutionIntramuscular, Intravenous | Baxter Healthcare Corporation | 43066-121 | 43066-0121-10 |
| Diazepam | Diazepam 20 mg/4mL | Injection, SolutionIntramuscular, Intravenous | Baxter Healthcare Corporation | 43066-123 | 43066-0123-10 |
| Diazepam | Diazepam 10 mg/2mL | Injection, SolutionIntramuscular, Intravenous | REMEDYREPACK INC. | 70518-4704 | 70518-4704-00 |
| Diazepam | Diazepam 5 mg/mL | Injection, SolutionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6283 | 00641-6283-25 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-025 | 87441-0025-01 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-026 | 87441-0026-01 |
| Diazepam | Diazepam 5 mg/1 | TabletOral | Coupler LLC | 67046-0943 | 67046-0943-03 |
| Diazepam | Diazepam 10 mg/1 | TabletOral | Coupler LLC | 67046-0944 | 67046-0944-03 |
| Diazepam | Diazepam 5 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9762 | 00404-9762-10 |
Other NDCs under ANDA 217468
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 |
|---|---|---|---|---|
| Diazepam | Diazepam 2.5 mg/.5mL | GelRectal | Navinta LLC | 68475-802 |
| Diazepam | Diazepam 10 mg/2mL | GelRectal | Navinta LLC | 68475-803 |
| Diazepam | Diazepam 20 mg/4mL | GelRectal | Navinta LLC | 68475-804 |
| Diazepam | Diazepam 2.5 mg/.5mL | GelRectal | Zydus Pharmaceuticals USA Inc. | 70710-2078 |
| Diazepam | Diazepam 10 mg/2mL | GelRectal | Zydus Pharmaceuticals USA Inc. | 70710-2079 |