ZYLOPRIM
- Product NDC
- 65483-993
- 11-digit product format
- 654830993
- Labeler code
- 65483
- Product ID
- 65483-993_cec6bc7a-f20a-4216-8eb8-67fb1ba15ec7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- allopurinol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Prometheus Laboratories Inc.
- Application
- NDA016084
- Marketing category
- NDA
- Marketing start
- 1966-08-19
- Marketing end
- 0000-00-00
- Substance
- ALLOPURINOL
- Active strength
- 300 mg/1
- Pharmacologic classes
- Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0ee55bab-4ea8-ac26-c688-380cfbcd5c03 | Product name | 7 | 20260127 |
| de89a493-168f-43fa-9852-1f15e00dbb17 | Product name | 1 | 20221110 |
| 4a2a34d6-1853-423b-9e0c-360370b95802 | Product name | 1 | 20171006 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65483-993-10 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d69b-621f-e053-dbdaa90a74ad | PRODUCT INFORMATION ZYLOPRIM ® (allopurinol) 100-mg Scored Tablets and 300-mg Scored Tablets |
| 65483-993-50 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-d69b-621f-e053-dbdaa90a74ad | PRODUCT INFORMATION ZYLOPRIM ® (allopurinol) 100-mg Scored Tablets and 300-mg Scored Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65483-993-10 | ZYLOPRIM | 100 in 1 BOTTLE | TABLET | 100 | 2 | |
| 65483-993-50 | ZYLOPRIM | 500 in 1 BOTTLE | TABLET | 500 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65483-993-10 | EA - Each | 65483-993 | d5e8b099-7ff3-4d85-9539-4247a24e56b6 | 1 | 2012-07-24 |
| 65483-993-50 | EA - Each | 65483-993 | 5e82ec5e-c017-4b3b-84d2-bd554f059cf1 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| allopurinol | ACTIVE INGREDIENT | 63CZ7GJN5I | ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.] | 2 | |
| allopurinol | ACTIVE MOIETY | 63CZ7GJN5I | ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.] | 2 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.] | 2 | |
| lactose | INACTIVE INGREDIENT | J2B2A4N98G | ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.] | 2 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.] | 2 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.] | 2 | |
| starch, corn | INACTIVE INGREDIENT | O8232NY3SJ | ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.] | 2 | |
| starch, potato | INACTIVE INGREDIENT | 8I089SAH3T | ZYLOPRIM (ALLOPURINOL) TABLET [PROMETHEUS LABORATORIES INC.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197319 | allopurinol 100 MG Oral Tablet | PSN | 342832b5-1a32-4bea-bc49-ab0fd152154e | 2 |
| 197320 | allopurinol 300 MG Oral Tablet | PSN | 342832b5-1a32-4bea-bc49-ab0fd152154e | 2 |
| 213995 | ZYLOPRIM 100 MG Oral Tablet | PSN | 342832b5-1a32-4bea-bc49-ab0fd152154e | 2 |
| 213998 | ZYLOPRIM 300 MG Oral Tablet | PSN | 342832b5-1a32-4bea-bc49-ab0fd152154e | 2 |
| 213995 | allopurinol 100 MG Oral Tablet [Zyloprim] | SBD | 342832b5-1a32-4bea-bc49-ab0fd152154e | 2 |
| 213998 | allopurinol 300 MG Oral Tablet [Zyloprim] | SBD | 342832b5-1a32-4bea-bc49-ab0fd152154e | 2 |
| 197319 | allopurinol 100 MG Oral Tablet | SCD | 342832b5-1a32-4bea-bc49-ab0fd152154e | 2 |
| 197320 | allopurinol 300 MG Oral Tablet | SCD | 342832b5-1a32-4bea-bc49-ab0fd152154e | 2 |
| 213995 | Zyloprim 100 MG Oral Tablet | SY | 342832b5-1a32-4bea-bc49-ab0fd152154e | 2 |
| 213998 | Zyloprim 300 MG Oral Tablet | SY | 342832b5-1a32-4bea-bc49-ab0fd152154e | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 65483-993-10 | 65483099310 | 100 in 1 BOTTLE | Historical |
| 65483-993-50 | 65483099350 | 500 in 1 BOTTLE | Historical |