ELIQUIS SPRINKLE

Product NDC
0003-0898
11-digit product format
000030898
Labeler code
0003
Product ID
0003-0898_f96cb5ea-74e9-4751-883d-d18ef0d83640
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
apixaban
Dosage form
CAPSULE
Route
ORAL
Labeler
E.R. Squibb & Sons, L.L.C.
Application
NDA220073
Marketing category
NDA
Marketing start
2025-09-15
Substance
APIXABAN
Active strength
.15 mg/1
Pharmacologic classes
Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220073-001ELIQUIS SPRINKLEAPIXABAN0.15MGFOR SUSPENSION / ORALRLD, RS2025-04-17

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220073-00169672082026-11-21U-4180Drug substance, Drug product2025-05-16
N220073-0016967208*PED2027-05-21Pediatric extension
N220073-001118965862040-11-22U-4180Drug product2025-05-16
N220073-00111896586*PED2041-05-22Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220073-001NP2028-04-17
N220073-001PED2028-10-17

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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N220073-001ELIQUIS SPRINKLE0.15MGFOR SUSPENSION / ORALRLD, RS2025-04-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220073-001ELIQUIS SPRINKLE0.15MGFOR SUSPENSION / ORALRLD, RS2025-04-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N220073-001ELIQUIS SPRINKLE0.15MGFOR SUSPENSION / ORALRLD, RS2025-04-176a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220073-001ELIQUIS SPRINKLE0.15MGFOR SUSPENSION / ORALRLD, RS2025-04-17a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N220073-00169672082026-11-21U-4180Drug substance, Drug product2025-05-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220073-0016967208*PED2027-05-21Pediatric extension011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220073-001118965862040-11-22U-4180Drug product2025-05-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220073-00111896586*PED2041-05-22Pediatric extension011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220073-00169672082026-11-21U-4180Drug substance, Drug product2025-05-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220073-0016967208*PED2027-05-21Pediatric extension31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220073-001118965862040-11-22U-4180Drug product2025-05-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220073-00111896586*PED2041-05-22Pediatric extension31067a03dcf5…
2025-08-23 18:47 UTC2025-08N220073-00169672082026-11-21U-4180Drug substance, Drug product2025-05-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220073-0016967208*PED2027-05-21Pediatric extension6a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220073-001118965862040-11-22U-4180Drug product2025-05-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220073-00111896586*PED2041-05-22Pediatric extension6a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220073-00169672082026-11-21U-4180Drug substance, Drug product2025-05-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220073-0016967208*PED2027-05-21Pediatric extensiona50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220073-001118965862040-11-22U-4180Drug product2025-05-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220073-00111896586*PED2041-05-22Pediatric extensiona50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N220073-001NP2028-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220073-001PED2028-10-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220073-001NP2028-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220073-001PED2028-10-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N220073-001NP2028-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220073-001PED2028-10-176a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220073-001NP2028-04-17a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220073-001PED2028-10-17a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
ELIQUIS SPRINKLE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIXABAN.15 mg/1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-0898-28EA - Each0003-0898342f9840-5ec1-4989-9a50-b412fd21dc7f12025-10-14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0003-0898-280000308982828 CAPSULE in 1 BOTTLE (0003-0898-28) 28 capsule2025-09-15NoNoCurrent