Medication-info.com Search Menu

Diazepam Injection (Valium): Uses, Side Effects and Dosage

Updated:
Facts
Status:
Prescription (Rx) Controlled substance Schedule IV Boxed warning
Strength:
5 mg/mL
Brand names:
Drug class:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Diazepam Injection

INSTRUCTIONS FOR USE

CAUTION: Certain glass syringes may malfunction, break or clog when connected to some Needleless Luer Access Devices (NLADs) and needles. This syringe has a larger internal syringe tip and an external collar (luer collar). The external collar must remain attached to the syringe. (See Figure 1) Spontaneous disconnection of this glass syringe from needles and NLADs with leakage of drug product may occur. Assure that the needle or NLAD is securely attached before beginning the injection. Visually inspect the glass syringe-needle or glass syringe–NLAD connection before and during drug administration.

Diazepam injection may be administered intramuscularly or intravenously. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  1. 1. Inspect the outer packaging (plastic tube) and the syringe label by verifying:
  2. - plastic tube integrity
  3. - drug name
  4. - drug strength
  5. - fill volume
  6. - route of administration
  7. - expiration date to be sure that the drug has not expired
  8. - sterile field applicability

Do not use if package has been damaged.

  1. 2. Open the outer packaging and remove the syringe from the tube.
  2. 3. Perform visual inspection on the syringe by verifying:
  3. - absence of syringe damage
  4. - absence of external particles
  5. - absence of internal particles
  6. - proper drug color
  7. 4. Push plunger rod slightly to break the stopper loose while tip cap is still on.
  8. 5. Remove tip cap by twisting it off. (See Figure 2)
  1. 6. Discard the tip cap.
  2. 7. Expel air bubble.
  3. 8. Adjust dose into sterile material (if applicable).
  4. 9. Connect the syringe to an appropriate injection connection depending on the route of administration.
  5. - Before injection, ensure that the syringe is securely attached to the needle or needleless luer access device (NLAD).
  6. 10. Depress plunger rod to deliver medication. Ensure that pressure is maintained on the plunger rod during the entire administration.
  7. 11. Remove syringe from NLAD (if applicable) and discard into appropriate receptacle.

When a needle is connected to the syringe, to prevent needle-stick injuries, needles must not be recapped.

NOTES:

  • All steps must be done sequentially
  • Do not autoclave syringe
  • Do not use this product on a sterile field
  • Do not introduce any other fluid into the syringe at any time
  • This product is for single dose only; discard unused portion

CAUTION: Federal (USA) law prohibits dispensing without prescription.

Distributed by:

Civica, Inc.

Lehi, Utah 84048

Manufactured by:

Hikma Pharmaceuticals USA Inc.

Berkeley Heights, NJ 07922

Revised: May 2026

462-136-00

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 070313 · View the label on DailyMed

Revision date stated in the text: May 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Diazepam Injection

Rx or OTC
Prescription (Rx), Controlled substance?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • This drug is a controlled substance under the federal Controlled Substances Act.
  • Rx
Controlled substance Schedule IVSchedule IV: low potential for abuse relative to Schedule III.
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Benzodiazepine
Active ingredient Diazepam 5 mg/mL
Dosage form Injection
Route Intramuscular, Intravenous
Marketing status listed in the FDA NDC Directory
Company (applicant) HIKMA
FDA approval ANDA 070313Abbreviated New Drug Application (ANDA) – generic drug Approved December 16, 1985
Therapeutic equivalence (TE) code APCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 11 labelers list this drug on DailyMed
Packages (NDC)
Package
5 mg/mL – 2 ml in 1 syringe / 10 in 1 carton NDC 72572-175-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.