Amoxicillin
- Product NDC
- 68071-5127
- 11-digit product format
- 680715127
- Labeler code
- 68071
- Product ID
- 68071-5127_1b548daa-2423-fc2f-e063-6394a90a8cc9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA065378
- Marketing category
- ANDA
- Marketing start
- 2007-03-26
- Substance
- AMOXICILLIN
- Active strength
- 400 mg/5mL
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMOXICILLIN | 400 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU |
| Rxcui | 308189 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-5127-5 | 2024-06-20 | C162847 | 48780-1 | ba0f9c33-20ff-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974 |
| 68071-5127-5 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-20ff-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974 |
| 68071-5127-5 | 2021-02-22 | C162847 | 48780-1 | ba0f9c33-20ff-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, and for Oral Suspension, USP, for oral administration Initial U.S. Approval: 1974 |
| 68071-5127-5 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-20ff-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN Capsules, Tablets and for Oral Suspension, USP. AMOXICILLIN Capsules, Tablets, 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 |
|---|
| 68071-5127-5 | Amoxicillin | 75 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 75 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-5127 | AMOXICILLIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240621_997650f9-7eff-64de-e053-2995a90a617b.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 |
|---|
| 68071-5127-5 | 68071512705 | 75 mL in 1 BOTTLE (68071-5127-5) | 75 ml | 2019-12-11 | 0000-00-00 | No | No | Current |