Amoxicillin
- Product NDC
- 10544-434
- 11-digit product format
- 105440434
- Labeler code
- 10544
- Product ID
- 10544-434_1ec9a16b-d696-1d4e-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Amoxicillin
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA065255
- Marketing category
- ANDA
- Marketing start
- 2014-02-07
- Marketing end
- 0000-00-00
- Substance
- AMOXICILLIN
- Active strength
- 875 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 |
|---|
| 10544-434-14 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4da4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use, see full prescribing information for Amoxicillin Tablets, USP. AMOXICILLIN tablets, USP, for oral administration Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. |
| 10544-434-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-4da4-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use, see full prescribing information for Amoxicillin Tablets, USP. AMOXICILLIN tablets, USP, for oral administration Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-434-14 | Amoxicillin | 14 in 1 BOTTLE | TABLET, COATED | 14 | | 5 |
| 10544-434-20 | Amoxicillin | 20 in 1 BOTTLE | TABLET, COATED | 20 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AMOXICILLIN | ACTIVE INGREDIENT | 804826J2HU | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | |
| AMOXICILLIN ANHYDROUS | ACTIVE MOIETY | 9EM05410Q9 | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-434 | AMOXICILLIN TABLET, COATED [BLENHEIM PHARMACAL, INC.] | 5 | Legacy NDC, 2 package rows | 20150903_0fc675ec-e756-274e-e054-00144ff88e88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-434-14 | 10544043414 | 14 in 1 BOTTLE | Historical |
| 10544-434-20 | 10544043420 | 20 in 1 BOTTLE | Historical |