NDC codes

FDA NDC Directory
Product NDC (as listed)51407-774Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51407-0774Add 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 NDC11-digit (billing)PackageCopy
51407-774-30514070774305140707743030 TABLET in 1 BOTTLE, PLASTIC (51407-774-30)Marketed from May 6, 2023

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)
Amlodipine and Valsartan
Generic name (nonproprietary)
amlodipine and valsartan
Active ingredients
Amlodipine — 10 mg/1Valsartan — 320 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Golden State Medical Supply, Inc.NDC labeler code 51407
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090011
Marketing start
Listing expires
Other FDA classes
Angiotensin 2 Receptor Antagonists (Mechanism)Calcium Channel Antagonists (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)Dihydropyridines (Chemical structure)
Identifiers
Product ID 51407-774_4f9c77d6-c13d-7ccb-e063-6394a90ae49fSPL ID 4f9c77d6-c13d-7ccb-e063-6394a90ae49fSPL set ID fed14445-1117-861a-e053-6294a90a2aa3RxCUI 722126, 722131, 722134, 722137UNII 80M03YXJ7I, 1J444QC288
Pharmacologic class
Angiotensin 2 Receptor Blocker; 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

N451407077430 followed by a unit qualifier and the quantity

Package 51407-0774-30. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Amlodipine and valsartan is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan is indicated for the treatment of hypertension, to lower blood pressure: In patients not adequately controlled on monotherapy ( 1 ) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals ( 1 ) Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Hypertension Amlodipine and valsartan is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51407-774

What is NDC 51407-774?
51407-774 is the product NDC for Amlodipine and Valsartan, Amlodipine 10 mg/1; Valsartan 320 mg/1 tablet, listed with the FDA by Golden State Medical Supply, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Amlodipine and Valsartan.
What is the active ingredient?
Amlodipine, Valsartan.
Who is the labeler?
Golden State Medical Supply, Inc., NDC labeler code 51407. 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 and Valsartan?
39 other product NDCs are listed under this name. See all Amlodipine and Valsartan 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 and Valsartan NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Amlodipine And ValsartanAmlodipine besylate 5 mg/1; Valsartan 320 mg/1Tablet, Film coatedOralCadila Pharmaceuticals Limited71209-02371209-0023-0171209-0023-04
Amlodipine And ValsartanAmlodipine besylate 10 mg/1; Valsartan 320 mg/1Tablet, Film coatedOralCadila Pharmaceuticals Limited71209-02471209-0024-0171209-0024-04
Amlodipine And ValsartanAmlodipine besylate 10 mg/1; Valsartan 160 mg/1Tablet, Film coatedOralCadila Pharmaceuticals Limited71209-02271209-0022-0171209-0022-04
Amlodipine And ValsartanAmlodipine besylate 5 mg/1; Valsartan 160 mg/1Tablet, Film coatedOralCadila Pharmaceuticals Limited71209-02171209-0021-0171209-0021-04
amlodipine and valsartanAmlodipine besylate 10 mg/1; Valsartan 320 mg/1TabletOralMacleods Pharmaceuticals Limited33342-28233342-0282-0733342-0282-1033342-0282-12
amlodipine and valsartanAmlodipine besylate 5 mg/1; Valsartan 160 mg/1TabletOralMacleods Pharmaceuticals Limited33342-27933342-0279-0733342-0279-1033342-0279-12
amlodipine and valsartanAmlodipine besylate 10 mg/1; Valsartan 160 mg/1TabletOralMacleods Pharmaceuticals Limited33342-28033342-0280-0733342-0280-1033342-0280-12
amlodipine and valsartanAmlodipine besylate 5 mg/1; Valsartan 320 mg/1TabletOralMacleods Pharmaceuticals Limited33342-28133342-0281-0733342-0281-1033342-0281-12
Amlodipine and ValsartanAmlodipine 5 mg/1; Valsartan 160 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-84423155-0844-0323155-0844-09
Amlodipine and ValsartanAmlodipine 10 mg/1; Valsartan 160 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-84523155-0845-0323155-0845-09

All 40 Amlodipine and Valsartan NDCs

Other NDCs under ANDA 090011

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

FDA NDC Directory listings under ANDA 090011
ProductStrengthForm · routeLabelerProduct NDC
Amlodipine and ValsartanAmlodipine 5 mg/1; Valsartan 160 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-844
Amlodipine and ValsartanAmlodipine 10 mg/1; Valsartan 160 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-845
Amlodipine and ValsartanAmlodipine 5 mg/1; Valsartan 320 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-846
Amlodipine and ValsartanAmlodipine 10 mg/1; Valsartan 320 mg/1TabletOralHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-847
Amlodipine and ValsartanAmlodipine 5 mg/1; Valsartan 160 mg/1TabletOralGolden State Medical Supply, Inc.51407-771
Amlodipine and ValsartanAmlodipine 5 mg/1; Valsartan 320 mg/1TabletOralGolden State Medical Supply, Inc.51407-772
Amlodipine and ValsartanAmlodipine 10 mg/1; Valsartan 160 mg/1TabletOralGolden State Medical Supply, Inc.51407-773

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