Amoxicillin
- Product NDC
- 10544-165
- 11-digit product format
- 105440165
- Labeler code
- 10544
- Product ID
- 10544-165_ffabdb16-54db-4f3e-a818-4fc1162637a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- TABLET, CHEWABLE
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA064013
- Marketing category
- ANDA
- Marketing start
- 2013-11-15
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 250 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 |
|---|
| 10544-165-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d117-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable). AMOXICILLIN Capsules USP, AMOXICILLIN for Oral Suspension USP, and AMOXICILLIN Tablets USP (Chewable) for oral use Initial U.S. Approval: 1974 To reduce the development of drug-res |
| 10544-165-40 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-d117-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable) safely and effectively. See full prescribing information for Amoxicillin Capsules USP, Amoxicillin for Oral Suspension USP, and Amoxicillin Tablets USP (Chewable). AMOXICILLIN Capsules USP, AMOXICILLIN for Oral Suspension USP, and AMOXICILLIN Tablets USP (Chewable) for oral use Initial U.S. Approval: 1974 To reduce the development of drug-res |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-165-30 | Amoxicillin | 30 in 1 BOTTLE | TABLET, CHEWABLE | 30 | | 3 |
| 10544-165-40 | Amoxicillin | 40 in 1 BOTTLE | TABLET, CHEWABLE | 40 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.] | 3 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.] | 3 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.] | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.] | 3 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.] | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-165 | AMOXICILLIN TABLET, CHEWABLE [BLENHEIM PHARMACAL, INC.] | 3 | Legacy NDC, 2 package rows | 20150801_e91786c4-f928-4419-bd57-eca11498a6e6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-165-30 | 10544016530 | 30 in 1 BOTTLE | Historical |
| 10544-165-40 | 10544016540 | 40 in 1 BOTTLE | Historical |