FDA.reportPublic FDA data

TEMODAR

Product NDC
0085-1425
11-digit product format
000851425
Labeler code
0085
Product ID
0085-1425_40ceddc0-83a2-4b3b-8953-fd0078a41133
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Merck Sharp & Dohme LLC
Application
NDA021029
Marketing category
NDA
Marketing start
1999-08-11
Substance
TEMOZOLOMIDE
Active strength
140 mg/1
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021029-001TEMODARTEMOZOLOMIDE5MGCAPSULE / ORALRLD1999-08-11
N021029-002TEMODARTEMOZOLOMIDE20MGCAPSULE / ORALRLD1999-08-11
N021029-003TEMODARTEMOZOLOMIDE100MGCAPSULE / ORALRLD1999-08-11
N021029-004TEMODARTEMOZOLOMIDE250MGCAPSULE / ORALRLD1999-08-11
N021029-005TEMODARTEMOZOLOMIDE140MGCAPSULE / ORALRLD2006-10-19
N021029-006TEMODARTEMOZOLOMIDE180MGCAPSULE / ORALRLD2006-10-19

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 7 · 252 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07N021029-005TEMODAR140MGCAPSULE / ORALRLD2006-10-19caaa826d4ba7…
2026-08-18 06:07:402026-07N021029-006TEMODAR180MGCAPSULE / ORALRLD2006-10-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021029-005TEMODAR140MGCAPSULE / ORALRLD2006-10-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021029-006TEMODAR180MGCAPSULE / ORALRLD2006-10-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021029-005TEMODAR140MGCAPSULE / ORALRLD2006-10-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021029-006TEMODAR180MGCAPSULE / ORALRLD2006-10-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021029-005TEMODAR140MGCAPSULE / ORALRLD2006-10-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021029-006TEMODAR180MGCAPSULE / ORALRLD2006-10-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021029-005TEMODAR140MGCAPSULE / ORALRLD2006-10-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021029-006TEMODAR180MGCAPSULE / ORALRLD2006-10-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021029-005TEMODAR140MGCAPSULE / ORALRLD2006-10-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021029-006TEMODAR180MGCAPSULE / ORALRLD2006-10-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021029-001TEMODAR5MGCAPSULE / ORALRLD1999-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021029-002TEMODAR20MGCAPSULE / ORALRLD1999-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021029-003TEMODAR100MGCAPSULE / ORALRLD1999-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021029-004TEMODAR250MGCAPSULE / ORALRLD1999-08-1103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021029-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021029-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021029-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021029-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021029-005AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021029-006AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021029-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021029-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021029-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021029-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021029-005AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021029-006AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021029-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021029-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021029-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021029-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021029-005AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021029-006AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021029-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021029-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021029-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021029-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021029-005AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021029-006AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021029-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021029-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021029-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021029-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021029-005AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021029-006AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021029-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021029-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021029-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021029-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021029-005AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021029-006AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021029-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021029-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021029-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021029-004AB187673890dc5c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMOZOLOMIDE140 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YF1K15M17YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
261288Internal RxNorm lookup
261289Internal RxNorm lookup
261290Internal RxNorm lookup
261291Internal RxNorm lookup
313209Internal RxNorm lookup
313210Internal RxNorm lookup
313211Internal RxNorm lookup
317160Internal RxNorm lookup
700883Internal RxNorm lookup
700885Internal RxNorm lookup
705617Internal RxNorm lookup
705619Internal RxNorm lookup
835945Internal RxNorm lookup
835948Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
046a9011-3911-4d3f-a15f-fbb56d5aad56Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
3afbbf09-a1e0-475e-b654-466d26d19d69Product name920170706
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0085-1425-03TEMODAR5 in 1 CARTONCAPSULE540
0085-1425-04TEMODAR14 in 1 CARTONCAPSULE1440
0085-1425-05TEMODAR1 in 1 PACKETCAPSULE140

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-1425-01EA - Each0085-1425921c2382-8a88-4e12-9281-156bb032114112012-07-24
0085-1425-02EA - Each0085-14257898d021-f070-42ae-8a78-f5f65566291512012-07-24
0085-1425-03EA - Each0085-1425eb37c288-d695-4ff8-8b02-5f5c88fe6e7612013-02-13
0085-1425-04EA - Each0085-142505c2b076-5f89-4056-842f-5b16a54e609412013-02-13
0085-1425-05EA - Each0085-1425f68ae5bf-d057-442f-93e0-3af57a7e337c12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TemozolomideACTIVE INGREDIENTYF1K15M17YTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
TemozolomideACTIVE MOIETYYF1K15M17YTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
alcoholINACTIVE INGREDIENT3K9958V90MTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
ferric oxide redINACTIVE INGREDIENT1K09F3G675TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
gelatinINACTIVE INGREDIENT2G86QN327LTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
hydrochloric acidINACTIVE INGREDIENTQTT17582CBTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
mannitolINACTIVE INGREDIENT3OWL53L36ATEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
shellacINACTIVE INGREDIENT46N107B71OTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
stearic acidINACTIVE INGREDIENT4ELV7Z65APTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
tartaric acidINACTIVE INGREDIENTW4888I119HTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
threonineINACTIVE INGREDIENT2ZD004190STEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
waterINACTIVE INGREDIENT059QF0KO0RTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0085-1425TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]38Current NDC, Legacy NDC, 3 package rows20241109_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TEMODARTEMOZOLOMIDEMerck Sharp & Dohme LLC046a9011-3911-4d3f-a15f-fbb56d5aad562026-02-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 021029
application number: NDA021029
ndc (product): 0085-1425

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835948Temodar 100 MG InjectionPSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
261290Temodar 100 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
705617Temodar 140 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
705619Temodar 180 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
261289Temodar 20 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
261291Temodar 250 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
261288Temodar 5 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
835945temozolomide 100 MG InjectionPSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
317160temozolomide 100 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
700883temozolomide 140 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
700885temozolomide 180 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
313209temozolomide 20 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
313210temozolomide 250 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
313211temozolomide 5 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
835948temozolomide 100 MG Injection [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
261290temozolomide 100 MG Oral Capsule [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
705617temozolomide 140 MG Oral Capsule [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
705619temozolomide 180 MG Oral Capsule [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
261289temozolomide 20 MG Oral Capsule [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
261291temozolomide 250 MG Oral Capsule [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
261288temozolomide 5 MG Oral Capsule [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
835945temozolomide 100 MG InjectionSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
317160temozolomide 100 MG Oral CapsuleSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
700883temozolomide 140 MG Oral CapsuleSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
700885temozolomide 180 MG Oral CapsuleSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
313209temozolomide 20 MG Oral CapsuleSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
313210temozolomide 250 MG Oral CapsuleSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
313211temozolomide 5 MG Oral CapsuleSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
835948Temodar 100 MG InjectionSY046a9011-3911-4d3f-a15f-fbb56d5aad5640
261290Temodar 100 MG Oral CapsuleSY046a9011-3911-4d3f-a15f-fbb56d5aad5640
705617Temodar 140 MG Oral CapsuleSY046a9011-3911-4d3f-a15f-fbb56d5aad5640
705619Temodar 180 MG Oral CapsuleSY046a9011-3911-4d3f-a15f-fbb56d5aad5640
261289Temodar 20 MG Oral CapsuleSY046a9011-3911-4d3f-a15f-fbb56d5aad5640
261291Temodar 250 MG Oral CapsuleSY046a9011-3911-4d3f-a15f-fbb56d5aad5640
261288Temodar 5 MG Oral CapsuleSY046a9011-3911-4d3f-a15f-fbb56d5aad5640

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0085-1425-03000851425035 PACKET in 1 CARTON (0085-1425-03) / 1 CAPSULE in 1 PACKET (0085-1425-05) 5 packet1999-08-110000-00-00NoNoCurrent
0085-1425-040008514250414 PACKET in 1 CARTON (0085-1425-04) / 1 CAPSULE in 1 PACKET (0085-1425-05) 14 packet1999-08-110000-00-00NoNoCurrent
0085-1425-05000851425051 in 1 PACKETHistorical