Pacerone
- Product NDC
- 67544-570
- 11-digit product format
- 675440570
- Labeler code
- 67544
- Product ID
- 67544-570_a77aeba2-5b50-43d0-8427-f02da6f614b0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amiodarone Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA075135
- Marketing category
- ANDA
- Marketing start
- 2011-01-19
- Marketing end
- 0000-00-00
- Substance
- AMIODARONE HYDROCHLORIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Cytochrome P450 2C9 Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],Antiarrhythmic [EPC],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67544-570-30 | Pacerone | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Amiodarone Hydrochloride | ACTIVE INGREDIENT | 976728SY6Z | PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| Amiodarone | ACTIVE MOIETY | N3RQ532IUT | PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| sodium starch glycolate type a potato | INACTIVE INGREDIENT | 5856J3G2A2 | PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67544-570 | PACERONE (AMIODARONE HYDROCHLORIDE) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 4 | Legacy NDC, 1 package rows | 20191227_2eceb4d5-0c47-49c3-8263-46f689388efe.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 |
|---|
| 67544-570-30 | 67544057030 | 30 TABLET in 1 BOTTLE, PLASTIC (67544-570-30) | 30 tablet | 2011-01-20 | 0000-00-00 | No | No | Current |