What is NDC 11534-203?

11534-203 is the product NDC for Diazepam, Diazepam 5 mg/1 tablet, listed with the FDA by Sunrise Pharmaceutical, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Sunrise Pharmaceutical, Inc., NDC labeler code 11534. 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?

118 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Diazepam NDC 11534-203 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)11534-203Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11534-0203Add 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
11534-203-01	1153402030111534020301	100 TABLET in 1 BOTTLE (11534-203-01)Marketed from Dec 10, 2024
11534-203-03	1153402030311534020303	1000 TABLET in 1 BOTTLE (11534-203-03)Marketed from Dec 10, 2024
11534-203-04	1153402030411534020304	500 TABLET in 1 BOTTLE (11534-203-04)Marketed from Dec 10, 2024

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): Diazepam
Generic name (nonproprietary): diazepam
Active ingredients: Diazepam — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Sunrise Pharmaceutical, Inc.NDC labeler code 11534
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 070464
Marketing start: Dec 9, 2024
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 11534-203_e95b8ea6-9d51-4621-bb87-a365121b08bbSPL ID e95b8ea6-9d51-4621-bb87-a365121b08bbSPL set ID 34ac0b9d-d4ad-4aaa-8bee-902365f4e9a8RxCUI 197589, 197590, 197591UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N411534020301 followed by a unit qualifier and the quantity

Package 11534-0203-01. 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 Dec 9, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS Diazepam tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam tablets may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam tablets are a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and parapl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11534-203

What is NDC 11534-203?: 11534-203 is the product NDC for Diazepam, Diazepam 5 mg/1 tablet, listed with the FDA by Sunrise Pharmaceutical, Inc.. It has 3 package NDCs, 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?: Sunrise Pharmaceutical, Inc., NDC labeler code 11534. 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?: 118 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.

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

Other Diazepam NDCs
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

All 119 Diazepam NDCs

Other NDCs under ANDA 070464

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

FDA NDC Directory listings under ANDA 070464
Product	Strength	Form · route	Labeler	Product NDC
Diazepam	Diazepam 10 mg/1	TabletOral	Sunrise Pharmaceutical, Inc.	11534-199
Diazepam	Diazepam 2 mg/1	TabletOral	Sunrise Pharmaceutical, Inc.	11534-202