What is NDC 68083-108?

68083-108 is the product NDC for Midazolam Hydrochloride, Midazolam hydrochloride 5 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Midazolam Hydrochloride?

14 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Midazolam Hydrochloride NDC 68083-108

NDC codes

FDA NDC Directory

Product NDC (as listed)68083-108Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68083-0108Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
68083-108-01	6808301080168083010801	10 VIAL, MULTI-DOSE in 1 CARTON (68083-108-01) / 5 mL in 1 VIAL, MULTI-DOSEMarketed from Jun 1, 2012
68083-108-02	6808301080268083010802	10 VIAL, MULTI-DOSE in 1 CARTON (68083-108-02) / 10 mL in 1 VIAL, MULTI-DOSEMarketed from Jun 1, 2012

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): Midazolam Hydrochloride
Generic name (nonproprietary): midazolam hydrochloride
Active ingredients: Midazolam hydrochloride — 5 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular, Intravenous
Labeler: Gland Pharma LimitedNDC labeler code 68083
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090850
Marketing start: Jun 1, 2012
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 68083-108_3b7a93cb-a43a-46d0-ad52-6fba91da232dSPL ID 3b7a93cb-a43a-46d0-ad52-6fba91da232dSPL set ID 81b2f48d-a05c-4301-8fee-761af220d44fRxCUI 311702UNII W7TTW573JJ
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.

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.

How CPT relates to drug billing

NDC on a medical claim

N468083010801 followed by a unit qualifier and the quantity

Package 68083-0108-01. 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 Oct 16, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Midazolam Injection is indicated: • intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; • intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; • intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a re…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68083-108

What is NDC 68083-108?: 68083-108 is the product NDC for Midazolam Hydrochloride, Midazolam hydrochloride 5 mg/mL injection, solution, listed with the FDA by Gland Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Midazolam Hydrochloride.
What is the active ingredient?: Midazolam hydrochloride.
Who is the labeler?: Gland Pharma Limited, NDC labeler code 68083. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Midazolam Hydrochloride?: 14 other product NDCs are listed under this name. See all Midazolam Hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Midazolam Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Midazolam Hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Jvet Pharmaceuticals LLC	86211-111	86211-0111-10
Midazolam Hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Belcher Pharmaceuticals, LLC	62250-111	62250-0111-10
Midazolam Hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9916	00404-9916-0100404-9916-02
Midazolam Hydrochloride	Midazolam hydrochloride 2 mg/mL	SyrupOral	American Health Packaging	60687-576	60687-0576-1060687-0576-86
Midazolam hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-600	23155-0600-41
Midazolam hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-601	23155-0601-4123155-0601-42
Midazolam Hydrochloride	Midazolam hydrochloride 2 mg/mL	SyrupOral	Precision Dose Inc.	68094-762	68094-0762-62
Midazolam Hydrochloride	Midazolam hydrochloride 2 mg/mL	SyrupOral	Precision Dose Inc.	68094-764	68094-0764-62
Midazolam hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous	Gland Pharma Limited	68083-106	68083-0106-01
Midazolam Hydrochloride	Midazolam hydrochloride 1 mg/mL	Injection, SolutionIntramuscular, Intravenous	A-S Medication Solutions	50090-5472	50090-5472-00

All 15 Midazolam Hydrochloride NDCs

Other NDCs under ANDA 090850

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 090850
Product	Strength	Form · route	Labeler	Product NDC
midazolammidazolam hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Sagent Pharmaceuticals	25021-661
Midazolam hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-601
Midazolam Hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Belcher Pharmaceuticals, LLC	62250-111
Midazolam Hydrochloride	Midazolam hydrochloride 5 mg/mL	Injection, SolutionIntramuscular, Intravenous	Jvet Pharmaceuticals LLC	86211-111