Hydroxychloroquine Sulfate
- Product NDC
- 53002-4850
- 11-digit product format
- 530024850
- Labeler code
- 53002
- Product ID
- 53002-4850_67d834e2-175e-422d-a355-9918e0b688e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydroxychloroquine Sulfate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA040133
- Marketing category
- ANDA
- Marketing start
- 2016-03-30
- Marketing end
- 0000-00-00
- Substance
- HYDROXYCHLOROQUINE SULFATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Antirheumatic Agent [EPC],Antimalarial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-4850-2 | Hydroxychloroquine Sulfate | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 3 |
| 53002-4850-6 | Hydroxychloroquine Sulfate | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-4850 | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 2 package rows | 20201218_1b49a98f-37a8-4b01-8a82-90b947bbc223.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-4850-2 | 53002485002 | 20 TABLET, FILM COATED in 1 BOTTLE (53002-4850-2) | 2018-10-01 | 0000-00-00 | No | No | Current |
| 53002-4850-6 | 53002485006 | 60 TABLET, FILM COATED in 1 BOTTLE (53002-4850-6) | 2018-10-01 | 0000-00-00 | No | No | Current |