FDA.reportPublic FDA data

Bleomycin

Product NDC
69097-364
11-digit product format
690970364
Labeler code
69097
Product ID
69097-364_0014ce7e-f3e5-467c-a1a4-6bf8c2aefd3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bleomycin
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
Labeler
Cipla USA Inc.
Application
ANDA209439
Marketing category
ANDA
Marketing start
2019-03-11
Marketing end
0000-00-00
Substance
BLEOMYCIN SULFATE
Active strength
15 [USP'U]/1
Pharmacologic classes
Cytoprotective Agent [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69097-364DDiscontinued by firm2026-08-17
excluded packagepackage69097-36469097-364-36DDiscontinued by firm2026-08-17

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209439-001BLEOMYCIN SULFATEBLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2019-03-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2019-03-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2019-03-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2019-03-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2019-03-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2019-03-113f01610625f2…
2019-09-15 20:21 UTC2019-09A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2019-03-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTIONAP2019-03-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209439-001BLEOMYCIN SULFATEEQ 15 UNITS BASE/VIALINJECTABLE / INJECTION2019-03-11e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A209439-001AP174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209439-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A209439-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209439-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209439-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209439-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A209439-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209439-001AP1ea99ee380514…

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-364BLEOMYCIN INJECTION [CIPLA USA INC.]1Legacy NDC20190402_497e462a-a295-4db1-9002-d2633efbd676.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-364-36690970364361 VIAL in 1 CARTON (69097-364-36) > 1 INJECTION in 1 VIAL1 vial2019-03-110000-00-00NoNoCurrent