Home NDC 0085-1381 TEMODAR
Product NDC 0085-1381
11-digit product format 000851381
Labeler code 0085
Product ID 0085-1381_40ceddc0-83a2-4b3b-8953-fd0078a41133
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Temozolomide
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Merck Sharp & Dohme LLC
Application NDA022277
Marketing category NDA
Marketing start 2009-02-27
Substance TEMOZOLOMIDE
Active strength 2.5 mg/mL
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [EPC]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022277-001 TEMODAR TEMOZOLOMIDE 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27
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 2 · 42 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 2026-08-18 06:07:40 2026-07 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022277-001 TEMODAR 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2009-02-27 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 2 · 72 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022277-001 7786118 2023-02-21 Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022277-001 6987108 2023-09-08 Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022277-001 7786118 2023-02-21 Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022277-001 6987108 2023-09-08 Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022277-001 7786118 2023-02-21 Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022277-001 6987108 2023-09-08 Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022277-001 7786118 2023-02-21 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022277-001 6987108 2023-09-08 Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022277-001 7786118 2023-02-21 Drug product bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022277-001 6987108 2023-09-08 Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022277-001 7786118 2023-02-21 Drug product 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022277-001 6987108 2023-09-08 Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022277-001 7786118 2023-02-21 Drug product 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022277-001 6987108 2023-09-08 Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022277-001 7786118 2023-02-21 Drug product 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N022277-001 6987108 2023-09-08 Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022277-001 7786118 2023-02-21 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022277-001 6987108 2023-09-08 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022277-001 7786118 2023-02-21 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022277-001 6987108 2023-09-08 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022277-001 7786118 2023-02-21 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022277-001 6987108 2023-09-08 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022277-001 7786118 2023-02-21 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022277-001 6987108 2023-09-08 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022277-001 7786118 2023-02-21 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022277-001 8623868 2023-02-21 Drug product 2014-01-28 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022277-001 6987108 2023-09-08 Drug product ea99ee380514…2023-12-20 04:57 UTC 2023-12 N022277-001 7786118 2023-02-21 Drug product ea1830bbd6c7…
Additional Listing Data#
Finished product Yes
Brand name base TEMODAR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TEMOZOLOMIDE 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YF1K15M17Y Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 14 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 261288 Internal RxNorm lookup 261289 Internal RxNorm lookup 261290 Internal RxNorm lookup 261291 Internal RxNorm lookup 313209 Internal RxNorm lookup 313210 Internal RxNorm lookup 313211 Internal RxNorm lookup 317160 Internal RxNorm lookup 700883 Internal RxNorm lookup 700885 Internal RxNorm lookup 705617 Internal RxNorm lookup 705619 Internal RxNorm lookup 835945 Internal RxNorm lookup 835948 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 0085-1381-01 TEMODAR 40 mL in 1 VIAL, SINGLE-USE INJECTION, POWDER, LYOPHILIZED, 40 40 0085-1381-01 TEMODAR 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 40
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Temozolomide ACTIVE INGREDIENT YF1K15M17Y TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 Temozolomide ACTIVE MOIETY YF1K15M17Y TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 alcohol INACTIVE INGREDIENT 3K9958V90M TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 ammonia INACTIVE INGREDIENT 5138Q19F1X TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 butyl alcohol INACTIVE INGREDIENT 8PJ61P6TS3 TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 FD&C Blue No. 2 INACTIVE INGREDIENT L06K8R7DQK TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 gelatin INACTIVE INGREDIENT 2G86QN327L TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 hydrochloric acid INACTIVE INGREDIENT QTT17582CB TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 mannitol INACTIVE INGREDIENT 3OWL53L36A TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 potassium hydroxide INACTIVE INGREDIENT WZH3C48M4T TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 shellac INACTIVE INGREDIENT 46N107B71O TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 sodium starch glycolate type A potato INACTIVE INGREDIENT 5856J3G2A2 TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 tartaric acid INACTIVE INGREDIENT W4888I119H TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 threonine INACTIVE INGREDIENT 2ZD004190S TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 trisodium citrate dihydrate INACTIVE INGREDIENT B22547B95K TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22 water INACTIVE INGREDIENT 059QF0KO0R TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0085-1381 TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC] 38 Current NDC, Legacy NDC, 2 package rows 20241109_046a9011-3911-4d3f-a15f-fbb56d5aad56.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 Marketing start Marketing end Sample Exclude flag Status 0085-1381-01 00085138101 1 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01) / 40 mL in 1 VIAL, SINGLE-USE 2009-02-27 0000-00-00 No No Current