What is NDC 71335-0843?

71335-0843 is the product NDC for Amlodipine besylate, Amlodipine besylate 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-0843

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0843Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0843Add 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
71335-0843-0	7133508430071335084300	7 TABLET in 1 BOTTLE (71335-0843-0)Marketed from Apr 4, 2024
71335-0843-1	7133508430171335084301	30 TABLET in 1 BOTTLE (71335-0843-1)Marketed from Feb 23, 2022
71335-0843-2	7133508430271335084302	90 TABLET in 1 BOTTLE (71335-0843-2)Marketed from Feb 23, 2022
71335-0843-3	7133508430371335084303	60 TABLET in 1 BOTTLE (71335-0843-3)Marketed from Feb 23, 2022
71335-0843-4	7133508430471335084304	120 TABLET in 1 BOTTLE (71335-0843-4)Marketed from Feb 23, 2022
71335-0843-5	7133508430571335084305	100 TABLET in 1 BOTTLE (71335-0843-5)Marketed from Feb 23, 2022
71335-0843-6	7133508430671335084306	800 TABLET in 1 BOTTLE (71335-0843-6)Marketed from Feb 23, 2022
71335-0843-7	7133508430771335084307	1000 TABLET in 1 BOTTLE (71335-0843-7)Marketed from Feb 23, 2022
71335-0843-8	7133508430871335084308	180 TABLET in 1 BOTTLE (71335-0843-8)Marketed from Feb 23, 2022
71335-0843-9	7133508430971335084309	10 TABLET in 1 BOTTLE (71335-0843-9)Marketed from Feb 23, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077955
Marketing start: Nov 2, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers: Product ID 71335-0843_d64fca06-e908-4f92-a45e-ffa7121bc712SPL ID d64fca06-e908-4f92-a45e-ffa7121bc712SPL set ID f968393f-47d2-4c16-b34f-93a9d61adb9eRxCUI 308135UNII 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

N471335084300 followed by a unit qualifier and the quantity

Package 71335-0843-00. 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 Apr 4, 2024.

Indications (excerpt from the label)

Amlodipine besylate tablets, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: Hypertension ( 1.1 ) 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 ) Chronic Stable Angina Vasospastic Angina (Prinzmetal’s or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension Amlodipine besylate tablet…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-0843

What is NDC 71335-0843?: 71335-0843 is the product NDC for Amlodipine besylate, Amlodipine besylate 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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 077955

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

FDA NDC Directory listings under ANDA 077955
Product	Strength	Form · route	Labeler	Product NDC
Amlodipine besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Bryant Ranch Prepack	63629-1023
Amlodipine besylate	Amlodipine besylate 5 mg/1	TabletOral	Bryant Ranch Prepack	63629-1024
Amlodipine besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Bryant Ranch Prepack	71335-0833
Amlodipine besylate	Amlodipine besylate 5 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-722
Amlodipine besylate	Amlodipine besylate 10 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	43353-989
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Legacy Pharmaceutical Packaging, LLC	68645-515
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Legacy Pharmaceutical Packaging, LLC	68645-516
Amlodipine Besylate	Amlodipine besylate 10 mg/1	TabletOral	Cipla USA Inc.	69097-838
Amlodipine Besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Cipla USA Inc.	69097-836
Amlodipine Besylate	Amlodipine besylate 5 mg/1	TabletOral	Cipla USA Inc.	69097-837
Amlodipine besylate	Amlodipine besylate 2.5 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-237
Amlodipine besylate	Amlodipine besylate 5 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-238
Amlodipine besylate	Amlodipine besylate 10 mg/1	TabletOral	Exelan Pharmaceuticals, Inc.	76282-239