carmustine

Product NDC
75907-327
11-digit product format
759070327
Labeler code
75907
Product ID
75907-327_8402d8f0-8c25-a6c2-2992-d1b87b993749
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carmustine
Dosage form
KIT
Route
INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA213207
Marketing category
ANDA
Marketing start
2025-10-01
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213207-001CARMUSTINECARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A213207-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-224b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-228869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213207-001CARMUSTINE100MG/VIALINJECTABLE / INJECTIONAP2020-10-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213207-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213207-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213207-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213207-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213207-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213207-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213207-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213207-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213207-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213207-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213207-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213207-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213207-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213207-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213207-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213207-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213207-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213207-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213207-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213207-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A213207-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213207-001AP18869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213207-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213207-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213207-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213207-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213207-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213207-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213207-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213207-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A213207-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213207-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213207-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213207-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213207-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213207-001AP1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
carmustine
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309012Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7653a069-9cde-9ebf-5ccf-670f1a3f82b3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bae01308-1b8b-469d-b5f8-5f7855ef8376Product name720250716
8f5e4eb6-eb6b-45c2-b18a-1d6819bcb788Product name120230125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-326-11carmustine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,30 mL100 mg in 30mL1
75907-327-11carmustine1 in 1 CARTONKIT11

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
carmustineCARMUSTINEDr. Reddy's Laboratories Inc.7653a069-9cde-9ebf-5ccf-670f1a3f82b32025-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213207
application number: ANDA213207
ndc (product): 75907-327
carmustineCARMUSTINEDr. Reddy's Laboratories Inc.b946c396-34fc-1845-1944-f16028a8447d2024-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213207
application number: ANDA213207

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309012carmustine 100 MG InjectionPSN7653a069-9cde-9ebf-5ccf-670f1a3f82b31
309012carmustine 100 MG InjectionSCD7653a069-9cde-9ebf-5ccf-670f1a3f82b31
309012BCNU 100 MG InjectionSY7653a069-9cde-9ebf-5ccf-670f1a3f82b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-326-117590703261130 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
75907-327-11759070327111 KIT in 1 CARTON (75907-327-11) * 3 mL in 1 VIAL (75907-328-11) * 30 mL in 1 VIAL, SINGLE-DOSE (75907-326-11) 1 kit2025-10-01NoNoCurrent