Home NDC 0703-4636 Zanosar
Product NDC 0703-4636
11-digit product format 007034636
Labeler code 0703
Product ID 0703-4636_a385f86b-b920-40b9-a988-f5340c1c1ff4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name streptozocin
Dosage form POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Teva Parenteral Medicines, Inc.
Application NDA050577
Marketing category NDA
Marketing start 2003-12-03
Marketing end 0000-00-00
Substance STREPTOZOCIN
Active strength 100 mg/mL
Pharmacologic classes Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 8 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 0703-4636-01 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 0703-4636-01 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 0703-4636-01 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 0703-4636-01 a1b67e2a42f9…c4cf2c586c0d…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N050577-001 ZANOSAR STREPTOZOCIN 1GM/VIAL INJECTABLE / INJECTION RLD 1982-05-07
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 · 43 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 2026-09-14 22:38:34 2026-08 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD 1982-05-07 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD 1982-05-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD 1982-05-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD 1982-05-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD 1982-05-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD 1982-05-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050577-001 ZANOSAR 1GM/VIAL INJECTABLE / INJECTION RLD, RS 1982-05-07 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded STREPTOZOCIN ACTIVE INGREDIENT 5W494URQ81 ZANOSAR (STREPTOZOCIN) POWDER, FOR SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 STREPTOZOCIN ACTIVE MOIETY 5W494URQ81 ZANOSAR (STREPTOZOCIN) POWDER, FOR SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ZANOSAR (STREPTOZOCIN) POWDER, FOR SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ZANOSAR (STREPTOZOCIN) POWDER, FOR SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0703-4636-01 00703463601 10 mL in 1 VIAL (0703-4636-01) 10 ml 2003-12-03 0000-00-00 No No Current