What is NDC 43386-281?

43386-281 is the product NDC for Diazepam, Diazepam 20 mg/4g gel, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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 43386-281 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-281Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0281Add 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
43386-281-02	43386028102	1 PACKAGE in 1 CARTON (43386-281-02) / 2 SYRINGE in 1 PACKAGE (43386-281-01) / 4 g in 1 SYRINGE (43386-281-03)Marketed from Oct 30, 2023 · Sample package

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 — 20 mg/4g
Dosage form: Gel
Route: Rectal
Labeler: Lupin Pharmaceuticals,Inc.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 091076
Marketing start: Oct 30, 2023
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Benzodiazepines (Chemical structure)
Identifiers: Product ID 43386-281_91b10d2a-111a-4f2b-8b9a-d9c5d4a783f5SPL ID 91b10d2a-111a-4f2b-8b9a-d9c5d4a783f5SPL set ID d99b68aa-b3dc-49c8-8894-3da255cd26b0RxCUI 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

N443386028102 followed by a unit qualifier and the quantity

Package 43386-0281-02. 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 Dec 10, 2025. 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 43386-281

What is NDC 43386-281?: 43386-281 is the product NDC for Diazepam, Diazepam 20 mg/4g gel, listed with the FDA by Lupin Pharmaceuticals,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?: Lupin Pharmaceuticals,Inc., NDC labeler code 43386. 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 5 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-026	87441-0026-01
Diazepam	Diazepam 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-025	87441-0025-01
Diazepam	Diazepam 10 mg/1	TabletOral	Coupler LLC	67046-0944	67046-0944-03
Diazepam	Diazepam 5 mg/1	TabletOral	Coupler LLC	67046-0943	67046-0943-03
Diazepam	Diazepam 5 mg/mL	InjectionIntramuscular, Intravenous	Henry Schein, Inc.	0404-9762	00404-9762-10

All 119 Diazepam NDCs

Other NDCs under ANDA 091076

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

FDA NDC Directory listings under ANDA 091076
Product	Strength	Form · route	Labeler	Product NDC
Diazepam	Diazepam 10 mg/2g	GelRectal	Lupin Pharmaceuticals,Inc.	43386-280