What is NDC 68682-650?

68682-650 is the product NDC for Diazepam, Diazepam 2.5 mg/.5mL gel, listed with the FDA by Oceanside Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

Oceanside Pharmaceuticals, NDC labeler code 68682. 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 68682-650 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68682-650Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68682-0650Add 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
68682-650-20	6868206502068682065020	2 SYRINGE, PLASTIC in 1 PACKAGE (68682-650-20) / .5 mL in 1 SYRINGE, PLASTICMarketed from Jul 29, 1997

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 — 2.5 mg/.5mL
Dosage form: Gel
Route: Rectal
Labeler: Oceanside PharmaceuticalsNDC labeler code 68682
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020648
Marketing start: Jul 29, 1997
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 68682-650_0e23d654-d8b9-af1c-e063-6294a90a6f14SPL ID 0e23d654-d8b9-af1c-e063-6294a90a6f14SPL set ID b1b2848b-b265-4f6f-9141-bf106dec0726RxCUI 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

N468682065020 followed by a unit qualifier and the quantity

Package 68682-0650-20. 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 Jan 4, 2024. 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.

Full label on DailyMed (opens in a new tab)

About NDC 68682-650

What is NDC 68682-650?: 68682-650 is the product NDC for Diazepam, Diazepam 2.5 mg/.5mL gel, listed with the FDA by Oceanside Pharmaceuticals. 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?: Oceanside Pharmaceuticals, NDC labeler code 68682. 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 NDA 020648

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

FDA NDC Directory listings under NDA 020648
Product	Strength	Form · route	Labeler	Product NDC
Diazepam	Diazepam 10 mg/2mL	GelRectal	Oceanside Pharmaceuticals	68682-652
Diazepam	Diazepam 20 mg/4mL	GelRectal	Oceanside Pharmaceuticals	68682-655