What is NDC 0904-6369?

0904-6369 is the product NDC for Amlodipine Besylate, Amlodipine besylate 2.5 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.

Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Amlodipine Besylate?

167 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amlodipine Besylate NDC 0904-6369 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0904-6369Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00904-6369Add 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
0904-6369-61	0090463696100904636961	100 BLISTER PACK in 1 CARTON (0904-6369-61) / 1 TABLET in 1 BLISTER PACKMarketed from Jan 20, 2013

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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): Amlodipine Besylate
Generic name (nonproprietary): amlodipine besylate
Active ingredients: Amlodipine besylate — 2.5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Major PharmaceuticalsNDC labeler code 0904
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078226
Marketing start: Jan 20, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 0904-6369_77bde698-3ec9-4c6d-8e77-1bc3e950778bSPL ID 77bde698-3ec9-4c6d-8e77-1bc3e950778bSPL set ID edf9b22c-e37e-4b4e-8a64-20bb036c7d2dRxCUI 197361, 308135, 308136UNII 864V2Q084H
Pharmacologic class: Calcium Channel Blocker; Dihydropyridine Calcium Channel Blocker

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

N400904636961 followed by a unit qualifier and the quantity

Package 00904-6369-61. 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 Jul 27, 2026.

Indications (excerpt from the label)

Amlodipine besylate tablets, USP are calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: • Hypertension ( 1.1 ) o Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. • Coronary Artery Disease ( 1.2 ) o Chronic Stable Angina o Vasospastic Angina (Prinzmetal's or Variant Angina) o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besy…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0904-6369

What is NDC 0904-6369?: 0904-6369 is the product NDC for Amlodipine Besylate, Amlodipine besylate 2.5 mg/1 tablet, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amlodipine Besylate.
What is the active ingredient?: Amlodipine besylate.
Who is the labeler?: Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amlodipine Besylate?: 167 other product NDCs are listed under this name. See all Amlodipine Besylate 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 Amlodipine Besylate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	American Health Packaging	60687-961	60687-0961-01
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	American Health Packaging	60687-972	60687-0972-01
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Direct_Rx	72189-689	72189-0689-90
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Coupler LLC	67046-1157	67046-1157-03
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-016	87441-0016-01
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-017	87441-0017-01
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Safecor Health LLC	48433-155	48433-0155-20
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Safecor Health LLC	48433-156	48433-0156-20
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Safecor Health LLC	48433-157	48433-0157-20
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4629	70518-4629-0070518-4629-02

All 168 Amlodipine Besylate NDCs

Other NDCs under ANDA 078226

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

FDA NDC Directory listings under ANDA 078226
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Major Pharmaceuticals	0904-6370
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Major Pharmaceuticals	0904-6371
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Safecor Health LLC	48433-155
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Safecor Health LLC	48433-156
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Safecor Health LLC	48433-157
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Cardinal Health 107, LLC	55154-6875
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-6892
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Cardinal Health 107, LLC	55154-8093
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Zydus Lifesciences Limited	65841-620
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Zydus Lifesciences Limited	65841-621
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Zydus Lifesciences Limited	65841-622
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-121
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-122
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Zydus Pharmaceuticals USA Inc.	68382-123