vancomycin hydrochloride
- Product NDC
- 62559-390
- 11-digit product format
- 625590390
- Labeler code
- 62559
- Product ID
- 62559-390_cf20df7a-8689-49f9-a77b-a0a832fea8fa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- vancomycin hydrochloride
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- NDA050606
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2015-10-26
- Substance
- VANCOMYCIN HYDROCHLORIDE
- Active strength
- 125 mg/1
- Pharmacologic classes
- Glycopeptide Antibacterial [EPC], Glycopeptides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- vancomycin hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VANCOMYCIN HYDROCHLORIDE | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 71WO621TJD |
| Rxcui | 313570, 313571 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-390-20 | vancomycin hydrochloride | 10 in 1 BLISTER PACK | CAPSULE | 10 | | 11 |
| 62559-390-20 | vancomycin hydrochloride | 2 in 1 CARTON | CAPSULE | 2 | | 11 |
| 62559-390-50 | vancomycin hydrochloride | 50 in 1 BOTTLE | CAPSULE | 50 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| vancomycin hydrochloride | ACTIVE INGREDIENT | 71WO621TJD | VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] | 1 | |
| vancomycin | ACTIVE MOIETY | 6Q205EH1VU | VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] | 1 | |
| FD&C Blue NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] | 1 | |
| Ferric Oxide Red | INACTIVE INGREDIENT | 1K09F3G675 | VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] | 1 | |
| Ferric Oxide Yellow | INACTIVE INGREDIENT | EX438O2MRT | VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] | 1 | |
| Ferrosoferric Oxide | INACTIVE INGREDIENT | XM0M87F357 | VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] | 1 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-390 | VANCOMYCIN HYDROCHLORIDE CAPSULE [ANI PHARMACEUTICALS, INC.] | 9 | Current NDC, Legacy NDC, 3 package rows | 20240802_3707ad2e-5c82-4111-a370-e518e5e7e4c5.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 |
|---|
| 62559-390-20 | 62559039020 | 2 BLISTER PACK in 1 CARTON (62559-390-20) / 10 CAPSULE in 1 BLISTER PACK | 2 blister pack | 2015-10-26 | 0000-00-00 | No | No | Current |
| 62559-390-50 | 62559039050 | 50 CAPSULE in 1 BOTTLE (62559-390-50) | 50 capsule | 2016-12-20 | 0000-00-00 | No | No | Current |