HYDROXYCHLOROQUINE SULFATE
- Product NDC
- 42385-971
- 11-digit product format
- 423850971
- Labeler code
- 42385
- Product ID
- 42385-971_5db4ef8e-532f-4bbe-94ec-489704e93be7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROXYCHLOROQUINE SULFATE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Laurus Labs Limited
- Application
- ANDA210959
- Marketing category
- ANDA
- Marketing start
- 2023-03-06
- Substance
- HYDROXYCHLOROQUINE SULFATE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Antimalarial [EPC], Antirheumatic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYDROXYCHLOROQUINE SULFATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROXYCHLOROQUINE SULFATE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8Q2869CNVH |
| Rxcui | 979092 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42385-971-01 | HYDROXYCHLOROQUINE SULFATE | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 42385-971-05 | HYDROXYCHLOROQUINE SULFATE | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
| 42385-971-11 | HYDROXYCHLOROQUINE SULFATE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
| 42385-971-60 | HYDROXYCHLOROQUINE SULFATE | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42385-971 | HYDROXYCHLOROQUINE SULFATE TABLET, FILM COATED [LAURUS LABS LIMITED] | 2 | Current NDC, 4 package rows | 20240125_04d8fdbf-8829-4469-a341-8af2a2d91ccc.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42385-971-01 | 42385097101 | 100 TABLET, FILM COATED in 1 BOTTLE (42385-971-01) | 2023-03-06 | No | No | Current |
| 42385-971-05 | 42385097105 | 500 TABLET, FILM COATED in 1 BOTTLE (42385-971-05) | 2023-03-06 | No | No | Current |
| 42385-971-11 | 42385097111 | 1000 TABLET, FILM COATED in 1 BOTTLE (42385-971-11) | 2023-03-06 | No | No | Current |
| 42385-971-60 | 42385097160 | 60 TABLET, FILM COATED in 1 BOTTLE (42385-971-60) | 2023-03-06 | No | No | Current |