JAKAFI XR
- Product NDC
- 50881-044
- Requested package NDC
- 50881-044-08
- 11-digit product format
- 508810044
- Labeler code
- 50881
- Product ID
- 50881-044_baf91401-9bd0-4ce6-a5c4-7ca5c572f106
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ruxolitinib
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Incyte Corporation
- Application
- NDA217180
- Marketing category
- NDA
- Marketing start
- 2026-05-01
- Substance
- RUXOLITINIB
- Active strength
- 44 mg/1
- Pharmacologic classes
- Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N217180-001 | JAKAFI XR | RUXOLITINIB PHOSPHATE | EQ 11MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2026-05-01 | |
| N217180-002 | JAKAFI XR | RUXOLITINIB PHOSPHATE | EQ 22MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2026-05-01 | |
| N217180-003 | JAKAFI XR | RUXOLITINIB PHOSPHATE | EQ 33MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2026-05-01 | |
| N217180-004 | JAKAFI XR | RUXOLITINIB PHOSPHATE | EQ 44MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2026-05-01 | |
| N217180-005 | JAKAFI XR | RUXOLITINIB PHOSPHATE | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2026-05-01 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N217180-001 | 11744832 | 2026-12-12 | U-3226 | 2026-05-28 | |
| N217180-001 | 11744832 | 2026-12-12 | U-3230 | 2026-05-28 | |
| N217180-001 | 8530485 | 2026-12-12 | Drug product | 2026-05-28 | |
| N217180-001 | 9079912 | 2026-12-12 | U-3226 | 2026-05-28 | |
| N217180-001 | 9079912 | 2026-12-12 | U-3227 | 2026-05-28 | |
| N217180-001 | 9079912 | 2026-12-12 | U-3228 | 2026-05-28 | |
| N217180-001 | 9079912 | 2026-12-12 | U-3230 | 2026-05-28 | |
| N217180-001 | 9206187 | 2026-12-12 | U-3227 | 2026-05-28 | |
| N217180-001 | 9206187 | 2026-12-12 | U-3228 | 2026-05-28 | |
| N217180-001 | 9814722 | 2026-12-12 | U-3226 | 2026-05-28 | |
| N217180-001 | 9814722 | 2026-12-12 | U-3230 | 2026-05-28 | |
| N217180-001 | 7598257 | 2027-12-24 | U-3227 | Drug substance, Drug product | 2026-05-28 |
| N217180-001 | 7598257 | 2027-12-24 | U-3228 | Drug substance, Drug product | 2026-05-28 |
| N217180-001 | 8415362 | 2027-12-24 | Drug substance, Drug product | 2026-05-28 | |
| N217180-001 | 10016429 | 2028-06-12 | U-3226 | 2026-05-28 | |
| N217180-001 | 10016429 | 2028-06-12 | U-3230 | 2026-05-28 | |
| N217180-001 | 11213528 | 2028-06-12 | Drug product | 2026-05-28 | |
| N217180-001 | 8722693 | 2028-06-12 | Drug substance, Drug product | 2026-05-28 | |
| N217180-001 | 8822481 | 2028-06-12 | U-3226 | 2026-05-28 | |
| N217180-001 | 8822481 | 2028-06-12 | U-3227 | 2026-05-28 | |
| N217180-001 | 8822481 | 2028-06-12 | U-3228 | 2026-05-28 | |
| N217180-001 | 8822481 | 2028-06-12 | U-3230 | 2026-05-28 | |
| N217180-001 | 8829013 | 2028-06-12 | U-3227 | 2026-05-28 | |
| N217180-001 | 8829013 | 2028-06-12 | U-3228 | 2026-05-28 | |
| N217180-001 | 7598257*PED | 2028-06-24 | Pediatric extension | ||
| N217180-001 | 8415362*PED | 2028-06-24 | Pediatric extension | ||
| N217180-001 | 10016429*PED | 2028-12-12 | Pediatric extension | ||
| N217180-001 | 11213528*PED | 2028-12-12 | Pediatric extension | ||
| N217180-001 | 8722693*PED | 2028-12-12 | Pediatric extension | ||
| N217180-001 | 8822481*PED | 2028-12-12 | Pediatric extension | ||
| N217180-001 | 8829013*PED | 2028-12-12 | Pediatric extension | ||
| N217180-001 | 10874616 | 2033-11-14 | Drug product | 2026-05-28 | |
| N217180-001 | 11576864 | 2033-11-14 | U-3226 | 2026-05-28 | |
| N217180-001 | 11576864 | 2033-11-14 | U-3227 | 2026-05-28 | |
| N217180-001 | 11576864 | 2033-11-14 | U-3228 | 2026-05-28 | |
| N217180-001 | 11576864 | 2033-11-14 | U-3230 | 2026-05-28 | |
| N217180-001 | 11576865 | 2033-11-14 | U-3226 | Drug product | 2026-05-28 |
| N217180-001 | 11576865 | 2033-11-14 | U-3227 | Drug product | 2026-05-28 |
| N217180-001 | 11576865 | 2033-11-14 | U-3228 | Drug product | 2026-05-28 |
| N217180-001 | 11576865 | 2033-11-14 | U-3230 | Drug product | 2026-05-28 |
| N217180-001 | 11896717 | 2033-11-14 | U-3226 | Drug product | 2026-05-28 |
| N217180-001 | 11896717 | 2033-11-14 | U-3227 | Drug product | 2026-05-28 |
| N217180-001 | 11896717 | 2033-11-14 | U-3228 | Drug product | 2026-05-28 |
| N217180-001 | 11896717 | 2033-11-14 | U-3230 | Drug product | 2026-05-28 |
| N217180-001 | 11337927 | 2034-01-17 | U-3226 | 2026-05-28 | |
| N217180-001 | 11337927 | 2034-01-17 | U-3227 | 2026-05-28 | |
| N217180-001 | 11337927 | 2034-01-17 | U-3228 | 2026-05-28 | |
| N217180-001 | 11337927 | 2034-01-17 | U-3230 | 2026-05-28 | |
| N217180-001 | 10874616*PED | 2034-05-14 | Pediatric extension | ||
| N217180-001 | 11576864*PED | 2034-05-14 | Pediatric extension | ||
| N217180-001 | 11576865*PED | 2034-05-14 | Pediatric extension | ||
| N217180-001 | 11896717*PED | 2034-05-14 | Pediatric extension | ||
| N217180-001 | 11337927*PED | 2034-07-17 | Pediatric extension | ||
| N217180-002 | 11744832 | 2026-12-12 | U-3226 | 2026-05-28 | |
| N217180-002 | 11744832 | 2026-12-12 | U-3230 | 2026-05-28 | |
| N217180-002 | 8530485 | 2026-12-12 | Drug product | 2026-05-28 | |
| N217180-002 | 9079912 | 2026-12-12 | U-3226 | 2026-05-28 | |
| N217180-002 | 9079912 | 2026-12-12 | U-3227 | 2026-05-28 | |
| N217180-002 | 9079912 | 2026-12-12 | U-3228 | 2026-05-28 | |
| N217180-002 | 9079912 | 2026-12-12 | U-3230 | 2026-05-28 | |
| N217180-002 | 9206187 | 2026-12-12 | U-3227 | 2026-05-28 | |
| N217180-002 | 9206187 | 2026-12-12 | U-3228 | 2026-05-28 | |
| N217180-002 | 9814722 | 2026-12-12 | U-3226 | 2026-05-28 | |
| N217180-002 | 9814722 | 2026-12-12 | U-3230 | 2026-05-28 | |
| N217180-002 | 7598257 | 2027-12-24 | U-3227 | Drug substance, Drug product | 2026-05-28 |
| N217180-002 | 7598257 | 2027-12-24 | U-3228 | Drug substance, Drug product | 2026-05-28 |
| N217180-002 | 8415362 | 2027-12-24 | Drug substance, Drug product | 2026-05-28 | |
| N217180-002 | 10016429 | 2028-06-12 | U-3226 | 2026-05-28 | |
| N217180-002 | 10016429 | 2028-06-12 | U-3230 | 2026-05-28 | |
| N217180-002 | 11213528 | 2028-06-12 | Drug product | 2026-05-28 | |
| N217180-002 | 8722693 | 2028-06-12 | Drug substance, Drug product | 2026-05-28 | |
| N217180-002 | 8822481 | 2028-06-12 | U-3226 | 2026-05-28 | |
| N217180-002 | 8822481 | 2028-06-12 | U-3227 | 2026-05-28 | |
| N217180-002 | 8822481 | 2028-06-12 | U-3228 | 2026-05-28 | |
| N217180-002 | 8822481 | 2028-06-12 | U-3230 | 2026-05-28 | |
| N217180-002 | 8829013 | 2028-06-12 | U-3227 | 2026-05-28 | |
| N217180-002 | 8829013 | 2028-06-12 | U-3228 | 2026-05-28 | |
| N217180-002 | 7598257*PED | 2028-06-24 | Pediatric extension | ||
| N217180-002 | 8415362*PED | 2028-06-24 | Pediatric extension | ||
| N217180-002 | 10016429*PED | 2028-12-12 | Pediatric extension |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N217180-001 | ODE* | 2028-09-22 |
| N217180-001 | PED | 2029-03-22 |
| N217180-002 | ODE* | 2028-09-22 |
| N217180-002 | PED | 2029-03-22 |
| N217180-003 | ODE* | 2028-09-22 |
| N217180-003 | PED | 2029-03-22 |
| N217180-004 | ODE* | 2028-09-22 |
| N217180-004 | PED | 2029-03-22 |
| N217180-005 | ODE* | 2028-09-22 |
| N217180-005 | PED | 2029-03-22 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | JAKAFI XR | EQ 11MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2026-05-01 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-002 | JAKAFI XR | EQ 22MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2026-05-01 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-003 | JAKAFI XR | EQ 33MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2026-05-01 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-004 | JAKAFI XR | EQ 44MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD | 2026-05-01 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-005 | JAKAFI XR | EQ 55MG BASE | TABLET, EXTENDED RELEASE / ORAL | RLD, RS | 2026-05-01 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 11744832 | 2026-12-12 | U-3226 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 11744832 | 2026-12-12 | U-3230 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8530485 | 2026-12-12 | Drug product | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 9079912 | 2026-12-12 | U-3227 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 9079912 | 2026-12-12 | U-3228 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 9079912 | 2026-12-12 | U-3230 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 9079912 | 2026-12-12 | U-3226 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 9206187 | 2026-12-12 | U-3227 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 9206187 | 2026-12-12 | U-3228 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 9814722 | 2026-12-12 | U-3226 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 9814722 | 2026-12-12 | U-3230 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 7598257 | 2027-12-24 | U-3227 | Drug substance, Drug product | 2026-05-28 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 7598257 | 2027-12-24 | U-3228 | Drug substance, Drug product | 2026-05-28 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8415362 | 2027-12-24 | Drug substance, Drug product | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 10016429 | 2028-06-12 | U-3226 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 10016429 | 2028-06-12 | U-3230 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 11213528 | 2028-06-12 | Drug product | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8722693 | 2028-06-12 | Drug substance, Drug product | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8822481 | 2028-06-12 | U-3227 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8822481 | 2028-06-12 | U-3228 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8822481 | 2028-06-12 | U-3230 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8822481 | 2028-06-12 | U-3226 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8829013 | 2028-06-12 | U-3227 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8829013 | 2028-06-12 | U-3228 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 7598257*PED | 2028-06-24 | Pediatric extension | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8415362*PED | 2028-06-24 | Pediatric extension | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 10016429*PED | 2028-12-12 | Pediatric extension | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 11213528*PED | 2028-12-12 | Pediatric extension | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8722693*PED | 2028-12-12 | Pediatric extension | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8822481*PED | 2028-12-12 | Pediatric extension | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 8829013*PED | 2028-12-12 | Pediatric extension | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 10874616 | 2033-11-14 | Drug product | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 11576864 | 2033-11-14 | U-3227 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 11576864 | 2033-11-14 | U-3228 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 11576864 | 2033-11-14 | U-3230 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 11576864 | 2033-11-14 | U-3226 | 2026-05-28 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 11576865 | 2033-11-14 | U-3227 | Drug product | 2026-05-28 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 11576865 | 2033-11-14 | U-3228 | Drug product | 2026-05-28 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 11576865 | 2033-11-14 | U-3230 | Drug product | 2026-05-28 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | 11576865 | 2033-11-14 | U-3226 | Drug product | 2026-05-28 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | ODE* | 2028-09-22 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-001 | PED | 2029-03-22 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-002 | ODE* | 2028-09-22 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-002 | PED | 2029-03-22 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-003 | ODE* | 2028-09-22 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-003 | PED | 2029-03-22 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-004 | ODE* | 2028-09-22 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-004 | PED | 2029-03-22 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-005 | ODE* | 2028-09-22 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N217180-005 | PED | 2029-03-22 | a50c72e98297… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- JAKAFI XR
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| RUXOLITINIB | 44 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 82S8X8XX8H | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1193331 | Internal RxNorm lookup |
| 1193337 | Internal RxNorm lookup |
| 1193339 | Internal RxNorm lookup |
| 1193341 | Internal RxNorm lookup |
| 1193343 | Internal RxNorm lookup |
| 1193345 | Internal RxNorm lookup |
| 1193347 | Internal RxNorm lookup |
| 1193349 | Internal RxNorm lookup |
| 1193351 | Internal RxNorm lookup |
| 1193353 | Internal RxNorm lookup |
| 2743012 | Internal RxNorm lookup |
| 2743016 | Internal RxNorm lookup |
| 2743019 | Internal RxNorm lookup |
| 2743022 | Internal RxNorm lookup |
| 2743025 | Internal RxNorm lookup |
| 2743028 | Internal RxNorm lookup |
| 2743032 | Internal RxNorm lookup |
| 2743035 | Internal RxNorm lookup |
| 2743041 | Internal RxNorm lookup |
| 2743044 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f1c82580-87ae-11e0-bc84-0002a5d5c51b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 54477ffc-bf5d-4583-bcf6-d041bdba36f1 | Product name | 1 | 20220316 |
| 95a946d8-a784-4eb7-bff4-2194e4331c6f | Product name | 1 | 20190828 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50881-044-08 | JAKAFI XR | 30 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 30 | 40 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| RUXOLITINIB | ACTIVE INGREDIENT | 82S8X8XX8H | JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION] | 13 | |
| RUXOLITINIB | ACTIVE MOIETY | 82S8X8XX8H | JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION] | 13 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION] | 13 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION] | 13 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION] | 13 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION] | 13 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION] | 13 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION] | 13 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | JAKAFI (RUXOLITINIB) TABLET [INCYTE CORPORATION] | 13 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| JAKAFI | RUXOLITINIB | Incyte Corporation | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 2026-07-20 | Warnings, Adverse reactions | 217180 NDA217180 50881-044-08 50881-044 50881004408 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1193337 | Jakafi 10 MG Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193345 | Jakafi 15 MG Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193349 | Jakafi 20 MG Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193353 | Jakafi 25 MG Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193341 | Jakafi 5 MG Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743016 | Jakafi XR 11 MG 24HR Extended Release Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743022 | Jakafi XR 22 MG 24HR Extended Release Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743028 | Jakafi XR 33 MG 24HR Extended Release Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743035 | Jakafi XR 44 MG 24HR Extended Release Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743044 | Jakafi XR 55 MG 24HR Extended Release Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193331 | ruxolitinib 10 MG Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743012 | ruxolitinib 11 MG 24HR Extended Release Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193343 | ruxolitinib 15 MG Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193347 | ruxolitinib 20 MG Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743019 | ruxolitinib 22 MG 24HR Extended Release Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193351 | ruxolitinib 25 MG Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743025 | ruxolitinib 33 MG 24HR Extended Release Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743032 | ruxolitinib 44 MG 24HR Extended Release Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193339 | ruxolitinib 5 MG Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743041 | ruxolitinib 55 MG 24HR Extended Release Oral Tablet | PSN | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743016 | 24 HR ruxolitinib 11 MG Extended Release Oral Tablet [Jakafi] | SBD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743022 | 24 HR ruxolitinib 22 MG Extended Release Oral Tablet [Jakafi] | SBD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743028 | 24 HR ruxolitinib 33 MG Extended Release Oral Tablet [Jakafi] | SBD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743035 | 24 HR ruxolitinib 44 MG Extended Release Oral Tablet [Jakafi] | SBD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743044 | 24 HR ruxolitinib 55 MG Extended Release Oral Tablet [Jakafi] | SBD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193337 | ruxolitinib 10 MG Oral Tablet [Jakafi] | SBD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193345 | ruxolitinib 15 MG Oral Tablet [Jakafi] | SBD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193349 | ruxolitinib 20 MG Oral Tablet [Jakafi] | SBD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193353 | ruxolitinib 25 MG Oral Tablet [Jakafi] | SBD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193341 | ruxolitinib 5 MG Oral Tablet [Jakafi] | SBD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743012 | 24 HR ruxolitinib 11 MG Extended Release Oral Tablet | SCD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743019 | 24 HR ruxolitinib 22 MG Extended Release Oral Tablet | SCD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743025 | 24 HR ruxolitinib 33 MG Extended Release Oral Tablet | SCD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743032 | 24 HR ruxolitinib 44 MG Extended Release Oral Tablet | SCD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743041 | 24 HR ruxolitinib 55 MG Extended Release Oral Tablet | SCD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193331 | ruxolitinib 10 MG Oral Tablet | SCD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193343 | ruxolitinib 15 MG Oral Tablet | SCD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193347 | ruxolitinib 20 MG Oral Tablet | SCD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193351 | ruxolitinib 25 MG Oral Tablet | SCD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193339 | ruxolitinib 5 MG Oral Tablet | SCD | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193337 | Jakafi (as ruxolitinib phosphate) 10 MG Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193337 | Jakafi 10 MG Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193345 | Jakafi 15 MG Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193349 | Jakafi 20 MG Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193353 | Jakafi 25 MG Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193341 | Jakafi 5 MG Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743016 | Jakafi XR 11 MG 24 HR Extended Release Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743022 | Jakafi XR 22 MG 24 HR Extended Release Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743028 | Jakafi XR 33 MG 24 HR Extended Release Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743035 | Jakafi XR 44 MG 24 HR Extended Release Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743044 | Jakafi XR 55 MG 24 HR Extended Release Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193331 | ruxolitinib (as ruxolitinib phosphate) 10 MG Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193343 | ruxolitinib (as ruxolitinib phosphate) 15 MG Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193347 | ruxolitinib (as ruxolitinib phosphate) 20 MG Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193351 | ruxolitinib (as ruxolitinib phosphate) 25 MG Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 1193339 | ruxolitinib (as ruxolitinib phosphate) 5 MG Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743012 | ruxolitinib 11 MG 24 HR Extended Release Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743019 | ruxolitinib 22 MG 24 HR Extended Release Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743025 | ruxolitinib 33 MG 24 HR Extended Release Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743032 | ruxolitinib 44 MG 24 HR Extended Release Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
| 2743041 | ruxolitinib 55 MG 24 HR Extended Release Oral Tablet | SY | f1c82580-87ae-11e0-bc84-0002a5d5c51b | 40 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 50881-044-08 | 50881004408 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50881-044-08) | 2026-05-01 | No | No | Current |