Home NDC 0310-1350-95 TAGRISSO
Product NDC 0310-1350
Requested package NDC 0310-1350-95
11-digit product format 003101350
Labeler code 0310
Product ID 0310-1350_d703b5ed-4b1c-44fe-8005-ebe3d8f563e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name osimertinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Application NDA208065
Marketing category NDA
Marketing start 2015-11-13
Substance OSIMERTINIB
Active strength 80 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Kinase Inhibitor [EPC], Kinase 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208065-001 TAGRISSO OSIMERTINIB MESYLATE EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 N208065-002 TAGRISSO OSIMERTINIB MESYLATE EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13
Orange Book patents# Current patent rows page 1 of 1 · 34 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208065-001 11524951 2032-07-25 Drug substance, Drug product 2023-01-11 N208065-001 9732058 2032-07-25 U-1777 Drug substance, Drug product 2017-08-29 N208065-001 9732058 2032-07-25 U-2289 Drug substance, Drug product 2017-08-29 N208065-001 9732058 2032-07-25 U-3016 Drug substance, Drug product 2017-08-29 N208065-001 9732058 2032-07-25 U-3823 Drug substance, Drug product 2017-08-29 N208065-001 9732058 2032-07-25 U-4010 Drug substance, Drug product 2017-08-29 N208065-001 8946235 2032-08-08 U-1777 Drug substance, Drug product 2015-12-11 N208065-001 8946235 2032-08-08 U-2289 Drug substance, Drug product 2015-12-11 N208065-001 8946235 2032-08-08 U-3016 Drug substance, Drug product 2015-12-11 N208065-001 8946235 2032-08-08 U-3823 Drug substance, Drug product 2015-12-11 N208065-001 8946235 2032-08-08 U-4010 Drug substance, Drug product 2015-12-11 N208065-001 10183020 2035-01-02 U-1777 Drug product 2019-02-12 N208065-001 10183020 2035-01-02 U-2289 Drug product 2019-02-12 N208065-001 10183020 2035-01-02 U-3016 Drug product 2019-02-12 N208065-001 10183020 2035-01-02 U-3823 Drug product 2019-02-12 N208065-001 10183020 2035-01-02 U-4010 Drug product 2019-02-12 N208065-001 12465608 2042-11-26 U-3823 2025-12-10 N208065-002 11524951 2032-07-25 Drug substance, Drug product 2023-01-11 N208065-002 9732058 2032-07-25 U-1777 Drug substance, Drug product 2017-08-29 N208065-002 9732058 2032-07-25 U-2289 Drug substance, Drug product 2017-08-29 N208065-002 9732058 2032-07-25 U-3016 Drug substance, Drug product 2017-08-29 N208065-002 9732058 2032-07-25 U-3823 Drug substance, Drug product 2017-08-29 N208065-002 9732058 2032-07-25 U-4010 Drug substance, Drug product 2017-08-29 N208065-002 8946235 2032-08-08 U-1777 Drug substance, Drug product 2015-12-11 N208065-002 8946235 2032-08-08 U-2289 Drug substance, Drug product 2015-12-11 N208065-002 8946235 2032-08-08 U-3016 Drug substance, Drug product 2015-12-11 N208065-002 8946235 2032-08-08 U-3823 Drug substance, Drug product 2015-12-11 N208065-002 8946235 2032-08-08 U-4010 Drug substance, Drug product 2015-12-11 N208065-002 10183020 2035-01-02 U-1777 Drug product 2019-02-12 N208065-002 10183020 2035-01-02 U-2289 Drug product 2019-02-12 N208065-002 10183020 2035-01-02 U-3016 Drug product 2019-02-12 N208065-002 10183020 2035-01-02 U-3823 Drug product 2019-02-12 N208065-002 10183020 2035-01-02 U-4010 Drug product 2019-02-12 N208065-002 12465608 2042-11-26 U-3823 2025-12-10
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 matching rows.
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.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208065-001 TAGRISSO EQ 40MG BASE TABLET / ORAL RLD 2015-11-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N208065-002 TAGRISSO EQ 80MG BASE TABLET / ORAL RLD, RS 2015-11-13 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 23 · 900 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208065-001 11524951 2032-07-25 Drug substance, Drug product 2023-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 9732058 2032-07-25 U-1777 Drug substance, Drug product 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 9732058 2032-07-25 U-2289 Drug substance, Drug product 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 9732058 2032-07-25 U-3016 Drug substance, Drug product 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 9732058 2032-07-25 U-4010 Drug substance, Drug product 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 9732058 2032-07-25 U-3823 Drug substance, Drug product 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 8946235 2032-08-08 U-1777 Drug substance, Drug product 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 8946235 2032-08-08 U-2289 Drug substance, Drug product 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 8946235 2032-08-08 U-3016 Drug substance, Drug product 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 8946235 2032-08-08 U-4010 Drug substance, Drug product 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 8946235 2032-08-08 U-3823 Drug substance, Drug product 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 10183020 2035-01-02 U-1777 Drug product 2019-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 10183020 2035-01-02 U-3016 Drug product 2019-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 10183020 2035-01-02 U-4010 Drug product 2019-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 10183020 2035-01-02 U-2289 Drug product 2019-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 10183020 2035-01-02 U-3823 Drug product 2019-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-001 12465608 2042-11-26 U-3823 2025-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 11524951 2032-07-25 Drug substance, Drug product 2023-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 9732058 2032-07-25 U-1777 Drug substance, Drug product 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 9732058 2032-07-25 U-2289 Drug substance, Drug product 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 9732058 2032-07-25 U-3016 Drug substance, Drug product 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 9732058 2032-07-25 U-4010 Drug substance, Drug product 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 9732058 2032-07-25 U-3823 Drug substance, Drug product 2017-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 8946235 2032-08-08 U-2289 Drug substance, Drug product 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 8946235 2032-08-08 U-1777 Drug substance, Drug product 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 8946235 2032-08-08 U-3016 Drug substance, Drug product 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 8946235 2032-08-08 U-4010 Drug substance, Drug product 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 8946235 2032-08-08 U-3823 Drug substance, Drug product 2015-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 10183020 2035-01-02 U-1777 Drug product 2019-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 10183020 2035-01-02 U-2289 Drug product 2019-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 10183020 2035-01-02 U-3016 Drug product 2019-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 10183020 2035-01-02 U-4010 Drug product 2019-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 10183020 2035-01-02 U-3823 Drug product 2019-02-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208065-002 12465608 2042-11-26 U-3823 2025-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208065-001 11524951 2032-07-25 Drug substance, Drug product 2023-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208065-001 9732058 2032-07-25 U-1777 Drug substance, Drug product 2017-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208065-001 9732058 2032-07-25 U-2289 Drug substance, Drug product 2017-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208065-001 9732058 2032-07-25 U-3016 Drug substance, Drug product 2017-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208065-001 9732058 2032-07-25 U-4010 Drug substance, Drug product 2017-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208065-001 9732058 2032-07-25 U-3823 Drug substance, Drug product 2017-08-29 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 8 · 292 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TAGRISSO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OSIMERTINIB 80 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3C06JJ0Z2O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1721565 Internal RxNorm lookup 1721571 Internal RxNorm lookup 1721581 Internal RxNorm lookup 1721583 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0310-1350-30 TAGRISSO 30 in 1 BOTTLE TABLET, FILM COATED 30 36 0310-1350-95 TAGRISSO 1 in 1 CARTON TABLET, FILM COATED 1 36 0310-1350-95 TAGRISSO 10 in 1 BLISTER PACK TABLET, FILM COATED 10 36 0310-1350-99 TAGRISSO 10 in 1 BOTTLE TABLET, FILM COATED 10 36
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded OSIMERTINIB ACTIVE INGREDIENT 3C06JJ0Z2O TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1 OSIMERTINIB ACTIVE MOIETY 3C06JJ0Z2O TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-1350 TAGRISSO (OSIMERTINIB) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 35 Current NDC, Legacy NDC, 4 package rows 20250228_5e81b4a7-b971-45e1-9c31-29cea8c87ce7.zip
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.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0310-1350-95 00310135095 1 BLISTER PACK in 1 CARTON (0310-1350-95) > 10 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2019-03-15 0000-00-00 Yes No Current