Home NDC 70377-022 Pemetrexed
Product NDC 70377-022
11-digit product format 703770022
Labeler code 70377
Product ID 70377-022_6d4ae8c8-40b6-2432-fea5-1efec84852e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pemetrexed disodium
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Biocon Pharma Inc
Application ANDA211090
Marketing category ANDA
Marketing start 2022-12-31
Marketing end 0000-00-00
Substance PEMETREXED DISODIUM HEMIPENTAHYDRATE
Active strength 1000 mg/40mL
Pharmacologic classes Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211090-001 PEMETREXED DISODIUM PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25
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 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 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS AP 2022-05-25 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211090-001 PEMETREXED DISODIUM EQ 1GM BASE/VIAL POWDER / INTRAVENOUS 2022-05-25 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70377-022-11 Pemetrexed 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 7 70377-022-11 Pemetrexed 40 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 40 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70377-022 PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BIOCON PHARMA INC] 7 Legacy NDC, 2 package rows 20240112_21a607a6-1ec3-e61b-7d89-c71e3bdc2e3b.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 70377-022-11 70377002211 1 in 1 CARTON Historical