Allopurinol
- Product NDC
- 68083-380
- 11-digit product format
- 680830380
- Labeler code
- 68083
- Product ID
- 68083-380_6a0eaf66-34ca-4ba5-a2c6-a3c369ddf30c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Allopurinol
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA212363
- Marketing category
- ANDA
- Marketing start
- 2022-01-26
- Substance
- ALLOPURINOL SODIUM
- Active strength
- 500 mg/25mL
- Pharmacologic classes
- Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Allopurinol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALLOPURINOL SODIUM | 500 mg/25mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 428673RC2Z |
| Rxcui | 252931 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-380-01 | Allopurinol | 25 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 25 | | 6 |
| 68083-380-01 | Allopurinol | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-380 | ALLOPURINOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] | 6 | Current NDC, Legacy NDC, 2 package rows | 20220325_4839e842-511e-4c72-9153-2b7e4e1954e2.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 |
|---|
| 68083-380-01 | 68083038001 | 1 VIAL, GLASS in 1 CARTON (68083-380-01) / 25 mL in 1 VIAL, GLASS | 2022-01-26 | 0000-00-00 | No | No | Current |