Amiodarone Hydrochloride
- Product NDC
- 51672-4055
- 11-digit product format
- 516724055
- Labeler code
- 51672
- Product ID
- 51672-4055_4cc4c3cb-aced-a125-e063-6394a90aee93
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA075424
- Marketing category
- ANDA
- Marketing start
- 2001-03-30
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Antiarrhythmic [EPC], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amiodarone Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMIODARONE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 976728SY6Z |
| Rxcui | 833528, 834348, 835956, 835960 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51672-4055-6 | Amiodarone Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Amiodarone Hydrochloride | ACTIVE INGREDIENT | 976728SY6Z | AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 9 | |
| Amiodarone | ACTIVE MOIETY | N3RQ532IUT | AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 9 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 9 | |
| anhydrous lactose | INACTIVE INGREDIENT | 3SY5LH9PMK | AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 9 | |
| D&C yellow No. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 9 | |
| FD&C yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 9 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 9 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 9 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 9 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | AMIODARONE HYDROCHLORIDE TABLET [TARO PHARMACEUTICALS U.S.A., INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51672-4055 | AMIODARONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 18 | Current NDC, Legacy NDC, 1 package rows | 20250406_7ccd3733-c3af-4a11-8500-0f99194c1472.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51672-4055-6 | 51672405506 | 30 TABLET in 1 BOTTLE (51672-4055-6) | 30 tablet | 2001-03-30 | 0000-00-00 | No | No | Current |