Amoxicillin
- Product NDC
- 10544-958
- 11-digit product format
- 105440958
- Labeler code
- 10544
- Product ID
- 10544-958_32949847-4166-404f-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc
- Application
- ANDA064076
- Marketing category
- ANDA
- Marketing start
- 2016-01-15
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC],Penicillins [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 10544-958-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1c32-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN Capsules and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules and for Oral Suspension, USP. AMOXICILLIN Capsules and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974 |
| 10544-958-21 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1c32-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN Capsules and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules and for Oral Suspension, USP. AMOXICILLIN Capsules and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974 |
| 10544-958-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1c32-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN Capsules and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules and for Oral Suspension, USP. AMOXICILLIN Capsules and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974 |
| 10544-958-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1c32-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use AMOXICILLIN Capsules and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules and for Oral Suspension, USP. AMOXICILLIN Capsules and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-958-20 | Amoxicillin | 20 in 1 BOTTLE | CAPSULE | 20 | | 4 |
| 10544-958-21 | Amoxicillin | 21 in 1 BOTTLE | CAPSULE | 21 | | 4 |
| 10544-958-30 | Amoxicillin | 30 in 1 BOTTLE | CAPSULE | 30 | | 4 |
| 10544-958-60 | Amoxicillin | 60 in 1 BOTTLE | CAPSULE | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-958 | AMOXICILLIN CAPSULE [BLENHEIM PHARMACAL, INC] | 4 | Legacy NDC, 4 package rows | 20160513_7f813093-98a2-452a-b6f1-132fe40f76c7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-958-20 | 10544095820 | 20 in 1 BOTTLE | Historical |
| 10544-958-21 | 10544095821 | 21 in 1 BOTTLE | Historical |
| 10544-958-30 | 10544095830 | 30 in 1 BOTTLE | Historical |
| 10544-958-60 | 10544095860 | 60 in 1 BOTTLE | Historical |