Home NDC 82449-002 Methylene blue
Product NDC 82449-002
11-digit product format 824490002
Labeler code 82449
Product ID 82449-002_4a8a9adf-f99b-6054-e063-6294a90ade62
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methylene Blue
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Steriscience Specialties Private Limited
Application ANDA216955
Marketing category ANDA
Marketing start 2025-02-28
Substance METHYLENE BLUE
Active strength 50 mg/10mL
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 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 A216955-001 METHYLENE BLUE METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-11-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216955-001 AP
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 A216955-001 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216955-001 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216955-001 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216955-001 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216955-001 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216955-001 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216955-001 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216955-001 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-11-22 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216955-001 METHYLENE BLUE 50MG/10ML (5MG/ML) SOLUTION / INTRAVENOUS AP 2024-11-22 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 50 mg/10mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1788984 Internal RxNorm lookup 2731634 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 82449-002-01 Methylene blue 10 mL in 1 AMPULE INJECTION, SOLUTION 10 3 82449-002-06 Methylene blue 5 in 1 CARTON INJECTION, SOLUTION 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82449-002 METHYLENE BLUE INJECTION, SOLUTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED] 1 Current NDC, 2 package rows 20250228_eb87d31c-3a8e-4089-9693-20bc17279650.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 82449-002-01 82449000201 10 mL in 1 AMPULE 10 ml Historical 82449-002-06 82449000206 5 AMPULE in 1 CARTON (82449-002-06) / 10 mL in 1 AMPULE (82449-002-01) 5 ampule 2025-02-28 No No Current