FDA.reportPublic FDA data

Paxlovid

Product NDC
0069-5045
11-digit product format
000695045
Labeler code
0069
Product ID
0069-5045_d20f905e-5c85-4ad4-ab46-871ce4f6669e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nirmatrelvir and ritonavir
Dosage form
KIT
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA217188
Marketing category
NDA
Marketing start
2025-07-09
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui900575, 2587897, 2587898, 2587899, 2599542, 2599543, 2704986, 2704987

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1d2364f5-8b1e-7c9a-4518-7b359d95fa50Product name220250116
00d976a9-a12a-db3d-ac4e-27498af714cfProduct name520250115
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
7a5f5ac7-15c0-4d8b-bea4-b3b28cb83a8dProduct name120231023
c8f34825-48cd-e7db-4048-c3be840a9308Product name520230123
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d1ee4fdb-1116-417b-8889-dc05571445b3Product name120160825
f8d26468-b1dc-49d8-a188-8b5d531405efProduct name120150731
0b1bb9d1-e628-4e7c-aada-fd6532257932Product name120150416
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
96979b26-bb9a-43d8-e3a6-d69b9e9f75e5Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-1345-11Paxlovid1 in 1 BLISTER PACKTABLET, FILM COATED10100 mg12
0069-2085-02Paxlovid2 in 1 BLISTER PACKTABLET, FILM COATED20150 mg12
0069-5045-06Paxlovid1 in 1 BLISTER PACKKIT112
0069-5045-30Paxlovid10 in 1 CARTONKIT1012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-5045-06EA - Each0069-5045c8588c2f-cac7-4ec0-a931-4fc5263050e212025-08-11
0069-5045-30EA - Each0069-504524ce323d-6c75-4615-bc15-d80e34d205c212025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-5045PAXLOVID (NIRMATRELVIR AND RITONAVIR) KIT [PFIZER LABORATORIES DIV PFIZER INC]8Current NDC, 4 package rows20250417_8a99d6d6-fd9e-45bb-b1bf-48c7f761232a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2599543{10 (nirmatrelvir 150 MG Oral Tablet) / 10 (ritonavir 100 MG Oral Tablet) } Pack [Paxlovid 150 MG /100 MG Dose Pack]BPCK8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2587899{20 (nirmatrelvir 150 MG Oral Tablet) / 10 (ritonavir 100 MG Oral Tablet) } Pack [Paxlovid 5-Day]BPCK8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2704987{6 (nirmatrelvir 150 MG Oral Tablet) / 5 (ritonavir 100 MG Oral Tablet) } Pack [Paxlovid 300 MG /100 MG ; 150 MG / 100 MG Dose Pack]BPCK8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2599542{10 (nirmatrelvir 150 MG Oral Tablet) / 10 (ritonavir 100 MG Oral Tablet) } PackGPCK8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2587898{20 (nirmatrelvir 150 MG Oral Tablet) / 10 (ritonavir 100 MG Oral Tablet) } PackGPCK8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2704986{6 (nirmatrelvir 150 MG Oral Tablet) / 5 (ritonavir 100 MG Oral Tablet) } PackGPCK8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2704986nirmatrelvir / ritonavir 300 MG /100 MG ; 150 MG / 100 MG Dose PackPSN8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2599542nirmatrelvir 150 MG ; ritonavir 100 MG Daily Dose Pack, RenalPSN8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2587897nirmatrelvir 150 MG Oral TabletPSN8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2587898nirmatrelvir 300 MG ; ritonavir 100 MG Daily Dose PackPSN8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2599543PAXLOVID 150 MG ; 100 MG Dose Pack, RenalPSN8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2704987PAXLOVID 300 MG ; 100 MG (Day 1), 150 MG ; 100 MG (Days 2-5) Dose PackPSN8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2587899PAXLOVID 300 MG ; 100 MG Dose PackPSN8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
900575ritonavir 100 MG Oral TabletPSN8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2587897nirmatrelvir 150 MG Oral TabletSCD8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
900575ritonavir 100 MG Oral TabletSCD8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2599542nirmatrelvir 150 MG Oral Tablet (10) / ritonavir 100 MG Oral Tablet (10) 150 MG /100 MG Dose PackSY8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2587898nirmatrelvir 150 MG Oral Tablet (20) / ritonavir 100 MG Oral Tablet (10) 5-Day PackSY8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2704986nirmatrelvir 150 MG Oral Tablet (6) / ritonavir 100 MG Oral Tablet (5) 300 MG /100 MG ; 150 MG / 100 MG Dose PackSY8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2599543Paxlovid 150 MG / 100 MG Dose PackSY8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2704987Paxlovid 300 MG / 100 MG ; 150 MG / 100 MG Dose PackSY8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12
2587899Paxlovid 300 MG / 100 MG Dose PackSY8a99d6d6-fd9e-45bb-b1bf-48c7f761232a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0069-1345-11000691345111 in 1 BLISTER PACKHistorical
0069-2085-02000692085022 in 1 BLISTER PACKHistorical
0069-5045-06000695045061 in 1 BLISTER PACKHistorical
0069-5045-300006950453010 BLISTER PACK in 1 CARTON (0069-5045-30) / 1 KIT in 1 BLISTER PACK (0069-5045-06) * 2 TABLET, FILM COATED in 1 BLISTER PACK (0069-2085-02) * 1 TABLET, FILM COATED in 1 BLISTER PACK (0069-1345-11) 10 blister pack2025-07-09NoNoHistorical