NDC codes

FDA NDC Directory
Product NDC (as listed)75907-005Labeler and product segments. Claims need a package NDC.
Product NDC at billing width75907-0005Add 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
75907-005-30759070005307590700053030 TABLET in 1 BOTTLE, PLASTIC (75907-005-30)Marketed from Mar 15, 2024

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)
Amiodarone Hydrochloride
Generic name (nonproprietary)
amiodarone hydrochloride
Active ingredients
Amiodarone hydrochloride — 100 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Dr. Reddy's Labratories Inc.NDC labeler code 75907
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075389
Marketing start
Marketing end
Other FDA classes
Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers
Product ID 75907-005_e0bc8f4a-dc9b-7804-4479-ebe732449569SPL ID e0bc8f4a-dc9b-7804-4479-ebe732449569SPL set ID 95cef33b-c0e6-b17c-7cbb-f5c066872705RxCUI 833528, 834348, 835956UNII 976728SY6ZUPC 0375907005305
Pharmacologic class
Antiarrhythmic

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

N475907000530 followed by a unit qualifier and the quantity

Package 75907-0005-30. 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)

Amiodarone hydrochloride tablets are indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. Amiodarone hydrochloride tablets is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 75907-005

What is NDC 75907-005?
75907-005 is the product NDC for Amiodarone Hydrochloride, Amiodarone hydrochloride 100 mg/1 tablet, listed with the FDA by Dr. Reddy's Labratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Amiodarone Hydrochloride.
What is the active ingredient?
Amiodarone hydrochloride.
Who is the labeler?
Dr. Reddy's Labratories Inc., NDC labeler code 75907. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amiodarone Hydrochloride?
61 other product NDCs are listed under this name. See all Amiodarone Hydrochloride 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 Amiodarone Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
amiodarone hydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralSafecor Health LLC48433-15448433-0154-20
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralMajor Pharmaceuticals0904-757600904-7576-61
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousHenry Schein, Inc.0404-977200404-9772-03
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousFresenius Kabi USA, LLC65219-64365219-0643-03
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousFresenius Kabi USA, LLC65219-64565219-0645-09
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousMedical Purchasing Solutions, LLC.71872-735471872-7354-01
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousSlate Run Pharmaceuticals70436-23270436-0232-5070436-0232-5270436-0232-62
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralDr. Reddy's Labratories Inc.75907-00675907-0006-60
Amiodarone HydrochlorideAmiodarone hydrochloride 50 mg/mLInjection, SolutionIntravenousMylan Institutional LLC72078-04672078-0046-0972078-0046-18
amiodarone hydrochlorideAmiodarone hydrochloride 100 mg/1TabletOralZydus Pharmaceuticals USA Inc.68382-29768382-0297-06

All 62 Amiodarone Hydrochloride NDCs

Other NDCs under ANDA 075389

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

FDA NDC Directory listings under ANDA 075389
ProductStrengthForm · routeLabelerProduct NDC
Amiodarone HydrochlorideAmiodarone hydrochloride 100 mg/1TabletOralAvPAK50268-097
Amiodarone HydrochlorideAmiodarone hydrochloride 200 mg/1TabletOralDr. Reddy's Labratories Inc.75907-006

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