Home NDC 0480-4516 Pemetrexed
Product NDC 0480-4516
11-digit product format 004804516
Labeler code 0480
Product ID 0480-4516_21155bd2-118e-4ce6-adb8-dddc69ae34c7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Pemetrexed
Dosage form SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Teva Pharmaceuticals, Inc.
Application NDA208419
Marketing category NDA
Marketing start 2022-06-01
Substance PEMETREXED MONOHYDRATE
Active strength 25 mg/mL
Pharmacologic classes Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
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 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208419-001 PEMETREXED PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 N208419-002 PEMETREXED PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 N208419-003 PEMETREXED PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21
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 3 · 114 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 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208419-002 PEMETREXED 500MG/20ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208419-003 PEMETREXED 1GM/40ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208419-001 PEMETREXED 100MG/4ML (25MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-08-21 1e350fbaab3a…
Additional Listing Data#
Finished product Yes
Brand name base Pemetrexed
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PEMETREXED MONOHYDRATE 25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 236Y2F7D9J Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2602363 Internal RxNorm lookup 2602365 Internal RxNorm lookup 2602366 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 0480-4516-01 Pemetrexed 4 mL in 1 VIAL, SINGLE-DOSE SOLUTION, CONCENTRATE 4 11 0480-4516-01 Pemetrexed 1 in 1 CARTON SOLUTION, CONCENTRATE 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-4516 PEMETREXED SOLUTION, CONCENTRATE [TEVA PHARMACEUTICALS, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20241109_8b660f68-b770-4e0a-b2f9-25e663deecc3.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 · 1 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 0480-4516-01 00480451601 1 VIAL, SINGLE-DOSE in 1 CARTON (0480-4516-01) / 4 mL in 1 VIAL, SINGLE-DOSE 2022-06-01 0000-00-00 No No Current