Rapamune
- Product NDC
- 0008-1041
- 11-digit product format
- 000081041
- Labeler code
- 0008
- Product ID
- 0008-1041_88b60b59-91f1-445d-a08f-a0a55c69d2d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SIROLIMUS
- Dosage form
- TABLET, SUGAR COATED
- Route
- ORAL
- Labeler
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
- Application
- NDA021110
- Marketing category
- NDA
- Marketing start
- 2001-07-01
- Marketing end
- 0000-00-00
- Substance
- SIROLIMUS
- Active strength
- 1 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SIROLIMUS | ACTIVE INGREDIENT | W36ZG6FT64 | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| SIROLIMUS | ACTIVE MOIETY | W36ZG6FT64 | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| CALCIUM SULFATE | INACTIVE INGREDIENT | WAT0DDB505 | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| GLYCERYL OLEATE | INACTIVE INGREDIENT | 4PC054V79P | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| POVIDONE K29/32 | INACTIVE INGREDIENT | 390RMW2PEQ | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] | 47 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0008-1041 | RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] | 73 | Legacy NDC | 20250110_3275b824-3f82-4151-2ab2-0036a9ba0acc.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0008-1041-05 | 00008104105 | 100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1041-05) | | 2001-07-01 | 0000-00-00 | No | No | Current |
| 0008-1041-10 | 00008104110 | 100 BLISTER PACK in 1 CARTON (0008-1041-10) > 1 TABLET, SUGAR COATED in 1 BLISTER PACK | 100 blister pack | 2001-07-01 | 0000-00-00 | No | No | Current |