Guardian Loratadine
- Product NDC
- 53041-285
- 11-digit product format
- 530410285
- Labeler code
- 53041
- Product ID
- 53041-285_af8cdd37-8fd0-4651-ae03-36c7d4863301
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Loratadine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Guardian Drug Company
- Application
- ANDA207569
- Marketing category
- ANDA
- Marketing start
- 2019-07-22
- Marketing end
- 0000-00-00
- Substance
- LORATADINE
- Active strength
- 10 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53041-285-21 | Guardian Loratadine | 1000 in 1 BOTTLE | TABLET | 1000 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53041-285 | GUARDIAN LORATADINE (LORATADINE) TABLET [GUARDIAN DRUG COMPANY] | 1 | Legacy NDC, 1 package rows | 20190723_af8cdd37-8fd0-4651-ae03-36c7d4863301.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 |
|---|
| 53041-285-21 | 53041028521 | 1000 TABLET in 1 BOTTLE (53041-285-21) | 1000 tablet | 2019-07-22 | 0000-00-00 | No | No | Current |