Home NDC 70771-1768 Methylene blue
Product NDC 70771-1768
11-digit product format 707711768
Labeler code 70771
Product ID 70771-1768_31d0470b-20e5-4d5e-b273-81d5dd6b2180
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylene blue
Dosage form INJECTION
Route INTRAVENOUS
Labeler Zydus Lifesciences Limited
Application ANDA215636
Marketing category ANDA
Marketing start 2023-12-05
Substance METHYLENE BLUE
Active strength 5 mg/mL
Pharmacologic classes Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A215636-001 METHYLENE BLUE METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 A215636-002 METHYLENE BLUE METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 A215636-003 METHYLENE BLUE METHYLENE BLUE 5MG/ML (5MG/ML) SOLUTION / INTRAVENOUS RS 2026-02-02 A215636-004 METHYLENE BLUE METHYLENE BLUE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RS 2026-03-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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.
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 2026-02-19 14:30 UTC 2026-02 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215636-003 METHYLENE BLUE 5MG/ML (5MG/ML) SOLUTION / INTRAVENOUS RS 2026-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215636-001 METHYLENE BLUE 10MG/2ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215636-002 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2023-12-05 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215636-003 METHYLENE BLUE 5MG/ML (5MG/ML) SOLUTION / INTRAVENOUS RS 2026-02-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215636-004 METHYLENE BLUE 100MG/10ML (10MG/ML) SOLUTION / INTRAVENOUS RS 2026-03-31 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Methylene blue
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHYLENE BLUE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T42P99266K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1737852 Internal RxNorm lookup 1788984 Internal RxNorm lookup 2199323 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 70771-1768-1 Methylene blue 10 mL in 1 VIAL INJECTION 10 3 70771-1768-5 Methylene blue 5 in 1 CARTON INJECTION 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1768 METHYLENE BLUE INJECTION [ZYDUS LIFESCIENCES LIMITED] 2 Current NDC, 2 package rows 20240426_df3568d6-d509-4c93-9a92-0e3d1d8514dc.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 Units Marketing start Sample Exclude flag Status 70771-1768-1 70771176801 10 mL in 1 VIAL 10 ml Historical 70771-1768-5 70771176805 5 VIAL in 1 CARTON (70771-1768-5) / 10 mL in 1 VIAL (70771-1768-1) 5 vial 2023-12-05 No No Current