Quinine Sulfate
- Product NDC
- 65162-811
- 11-digit product format
- 651620811
- Labeler code
- 65162
- Product ID
- 65162-811_b1b6d20f-5e99-4205-9f40-fa4a8af3416d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quinine
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA203729
- Marketing category
- ANDA
- Marketing start
- 2016-07-29
- Substance
- QUININE SULFATE
- Active strength
- 324 mg/1
- Pharmacologic classes
- Antimalarial [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quinine Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUININE SULFATE | 324 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | KF7Z0E0Q2B |
| Rxcui | 997010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-811-03 | Quinine Sulfate | 30 in 1 BOTTLE | CAPSULE | 30 | | 11 |
| 65162-811-09 | Quinine Sulfate | 90 in 1 BOTTLE | CAPSULE | 90 | | 11 |
| 65162-811-50 | Quinine Sulfate | 500 in 1 BOTTLE | CAPSULE | 500 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-811 | QUININE SULFATE (QUININE) CAPSULE [AMNEAL PHARMACEUTICALS LLC] | 11 | Current NDC, Legacy NDC, 3 package rows | 20241210_f567d5c7-ea5d-49a7-a035-b47208135f73.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 |
|---|
| 65162-811-03 | 65162081103 | 30 CAPSULE in 1 BOTTLE (65162-811-03) | 30 capsule | 2016-07-29 | 0000-00-00 | No | No | Current |
| 65162-811-09 | 65162081109 | 90 CAPSULE in 1 BOTTLE (65162-811-09) | 90 capsule | 2016-07-29 | 0000-00-00 | No | No | Current |
| 65162-811-50 | 65162081150 | 500 CAPSULE in 1 BOTTLE (65162-811-50) | 500 capsule | 2016-07-29 | 0000-00-00 | No | No | Current |