Home NDC 0703-4248 Carboplatin
Product NDC 0703-4248
11-digit product format 007034248
Labeler code 0703
Product ID 0703-4248_b943761e-6a46-45a0-bdb4-1fec1e101f8c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Carboplatin
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Teva Parenteral Medicines, Inc.
Application ANDA077269
Marketing category ANDA
Marketing start 2015-12-09
Substance CARBOPLATIN
Active strength 10 mg/mL
Pharmacologic classes Platinum-based Drug [EPC], Platinum-containing Compounds [EXT]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0703-4248-91 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0703-4248-91 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0703-4248-91 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0703-4248-91 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0703-4248-91 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0703-4248-91 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0703-4248-91 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0703-4248-91 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0703-4248-91 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0703-4248-91 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0703-4248-91 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0703-4248-91 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077269-001 CARBOPLATIN CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 A077269-002 CARBOPLATIN CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 A077269-003 CARBOPLATIN CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 A077269-004 CARBOPLATIN CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 5 · 168 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 A077269-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077269-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077269-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077269-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077269-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077269-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077269-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077269-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077269-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077269-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077269-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077269-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077269-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077269-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077269-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077269-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077269-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077269-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077269-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077269-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077269-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077269-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077269-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077269-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077269-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077269-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077269-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077269-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077269-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077269-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077269-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077269-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077269-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077269-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077269-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077269-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077269-001 CARBOPLATIN 50MG/5ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077269-002 CARBOPLATIN 150MG/15ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077269-003 CARBOPLATIN 450MG/45ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2004-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077269-004 CARBOPLATIN 600MG/60ML (10MG/ML) INJECTABLE / INTRAVENOUS AP 2007-12-28 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Carboplatin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBOPLATIN 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination BG3F62OND5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 597195 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 0703-4248-01 CARBOplatin 45 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 45 7 0703-4248-01 CARBOplatin 1 in 1 CARTON INJECTION, SOLUTION 1 7 0703-4248-81 Carboplatin 1 in 1 CARTON INJECTION, SOLUTION 1 5 0703-4248-81 Carboplatin 45 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 45 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CARBOPLATIN ACTIVE INGREDIENT BG3F62OND5 CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 4 CARBOPLATIN ACTIVE MOIETY BG3F62OND5 CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 4 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 4 WATER INACTIVE INGREDIENT 059QF0KO0R CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 4 CARBOPLATIN ACTIVE INGREDIENT BG3F62OND5 CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 2 CARBOPLATIN ACTIVE MOIETY BG3F62OND5 CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 2 CARBOPLATIN ACTIVE INGREDIENT BG3F62OND5 CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 1 CARBOPLATIN ACTIVE MOIETY BG3F62OND5 CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0703-4248 CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20221208_f330f5a2-2cad-402f-bcbb-26245a753276.zip 0703-4248 CARBOPLATIN INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20221006_e176b6ef-2ff6-498b-a9d8-7a634d147f37.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 · 2 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 0703-4248-01 00703424801 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4248-01) / 45 mL in 1 VIAL, MULTI-DOSE 2006-02-01 0000-00-00 No No Current 0703-4248-81 00703424881 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4248-81) / 45 mL in 1 VIAL, MULTI-DOSE 2015-12-09 0000-00-00 No No Current 0703-4248-91 00703424891 1 VIAL, MULTI-DOSE in 1 CARTON (0703-4248-91) > 45 mL in 1 VIAL, MULTI-DOSE 2015-06-04 0000-00-00 No No Current