Amoxicillin
- Product NDC
- 42708-010
- 11-digit product format
- 427080010
- Labeler code
- 42708
- Product ID
- 42708-010_5153c0f3-8cbe-a0fe-e063-6294a90a5d39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- QPharma, Inc
- Application
- ANDA061926
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- Substance
- AMOXICILLIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Penicillin-class Antibacterial [EPC], Penicillins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Amoxicillin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AMOXICILLIN | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 804826J2HU |
| Rxcui | 308191 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 42708-010-30 | 2021-03-12 | C162847 | 48780-1 | ba0f9c33-257b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A |
| 42708-010-30 | 2021-03-12 | C162847 | 48780-1 | ba0f9c33-257b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A |
| 42708-010-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-257b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A |
| 42708-010-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-257b-a910-e053-dadaa90a0b85 | These highlights do not include all the information needed to use AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES, safely and effectively. See full prescribing information for AMOXICILLIN TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), and AMOXICILLIN CAPSULES. AMOXICILLIN tablets, for oral use AMOXICILLIN for oral suspension, AMOXICILLIN tablets (chewable), for oral use AMOXICILLIN capsules, for oral use Initial U.S. A |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42708-010-30 | Amoxicillin | 30 in 1 BOTTLE | CAPSULE | 30 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42708-010 | AMOXICILLIN CAPSULE [QPHARMA, INC.] | 9 | Current NDC, Legacy NDC, 1 package rows | 20250521_60c788d1-6c91-4456-848a-893e649e90be.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 |
|---|
| 42708-010-30 | 42708001030 | 30 CAPSULE in 1 BOTTLE (42708-010-30) | 30 capsule | 2018-03-01 | 0000-00-00 | Yes | No | Current |