sirolimus
- Product NDC
- 68382-520
- 11-digit product format
- 683820520
- Labeler code
- 68382
- Product ID
- 68382-520_f54f3f24-5d0f-44a1-a4ca-03950954826f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sirolimus
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA201676
- Marketing category
- ANDA
- Marketing start
- 2014-01-15
- Substance
- SIROLIMUS
- Active strength
- .5 mg/1
- Pharmacologic classes
- Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR 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
- sirolimus
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SIROLIMUS | .5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | W36ZG6FT64 |
| Rxcui | 349208, 360110, 905158 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68382-520-01 | sirolimus | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 16 |
| 68382-520-05 | sirolimus | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 16 |
| 68382-520-06 | sirolimus | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 16 |
| 68382-520-10 | sirolimus | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 16 |
| 68382-520-16 | sirolimus | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 16 |
| 68382-520-30 | sirolimus | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 16 |
| 68382-520-77 | sirolimus | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SIROLIMUS | ACTIVE INGREDIENT | W36ZG6FT64 | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| SIROLIMUS | ACTIVE MOIETY | W36ZG6FT64 | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| ALPHA-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| CROSPOVIDONE | INACTIVE INGREDIENT | 68401960MK | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| GLYCERYL MONOOLEATE | INACTIVE INGREDIENT | 4PC054V79P | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68382-520 | SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] | 16 | Current NDC, Legacy NDC, 7 package rows | 20230720_ec473170-47f1-4a5c-b4d9-ac36406ed241.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 |
|---|
| 68382-520-01 | 68382052001 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-520-01) | | 2014-01-15 | 0000-00-00 | No | No | Current |
| 68382-520-05 | 68382052005 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-520-05) | | 2014-01-15 | 0000-00-00 | No | No | Current |
| 68382-520-06 | 68382052006 | 30 TABLET, FILM COATED in 1 BOTTLE (68382-520-06) | | 2014-01-15 | 0000-00-00 | No | No | Current |
| 68382-520-10 | 68382052010 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-520-10) | | 2014-01-15 | 0000-00-00 | No | No | Current |
| 68382-520-16 | 68382052016 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-520-16) | | 2014-01-15 | 0000-00-00 | No | No | Current |
| 68382-520-30 | 68382052030 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 68382-520-77 | 68382052077 | 10 BLISTER PACK in 1 CARTON (68382-520-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-520-30) | 10 blister pack | 2014-01-15 | 0000-00-00 | No | No | Current |