FDA.reportPublic FDA data

Lynparza

Product NDC
0310-0578
11-digit product format
003100578
Labeler code
0310
Product ID
0310-0578_0142c57f-6211-4638-8c48-c215686871b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olaparib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA208558
Marketing category
NDA
Marketing start
2017-08-17
Substance
OLAPARIB
Active strength
150 mg/1
Pharmacologic classes
Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase 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
Lynparza
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLAPARIB150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWOH1JD9AR8
Rxcui1942482, 1942485, 1942487, 1942489

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8aca7953-121c-4bc4-bc4b-c3dea9d035edProduct name120171006
74743eac-fb51-4dac-af6a-4c1391f918c9Product name120150225

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-0578-12Lynparza120 in 1 BOTTLETABLET, FILM COATED12038
0310-0578-60Lynparza60 in 1 BOTTLETABLET, FILM COATED6038

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-0578-12EA - Each0310-0578acced4b6-0b48-46a0-9928-25260383fe2f12025-03-04
0310-0578-60EA - Each0310-0578ccc5bbd5-a6fa-479d-b0e5-2b598e0bbb3112025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-0578LYNPARZA (OLAPARIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]37Current NDC, 2 package rows20250223_741ff3e3-dc1a-45a6-84e5-2481b27131aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1942485Lynparza 100 MG Oral TabletPSN741ff3e3-dc1a-45a6-84e5-2481b27131aa38
1942489Lynparza 150 MG Oral TabletPSN741ff3e3-dc1a-45a6-84e5-2481b27131aa38
1942482olaparib 100 MG Oral TabletPSN741ff3e3-dc1a-45a6-84e5-2481b27131aa38
1942487olaparib 150 MG Oral TabletPSN741ff3e3-dc1a-45a6-84e5-2481b27131aa38
1942485olaparib 100 MG Oral Tablet [Lynparza]SBD741ff3e3-dc1a-45a6-84e5-2481b27131aa38
1942489olaparib 150 MG Oral Tablet [Lynparza]SBD741ff3e3-dc1a-45a6-84e5-2481b27131aa38
1942482olaparib 100 MG Oral TabletSCD741ff3e3-dc1a-45a6-84e5-2481b27131aa38
1942487olaparib 150 MG Oral TabletSCD741ff3e3-dc1a-45a6-84e5-2481b27131aa38
1942485Lynparza 100 MG Oral TabletSY741ff3e3-dc1a-45a6-84e5-2481b27131aa38
1942489Lynparza 150 MG Oral TabletSY741ff3e3-dc1a-45a6-84e5-2481b27131aa38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0310-0578-1200310057812120 TABLET, FILM COATED in 1 BOTTLE (0310-0578-12) 2025-02-20NoNoCurrent
0310-0578-600031005786060 TABLET, FILM COATED in 1 BOTTLE (0310-0578-60) 2025-02-13NoNoCurrent