Home NDC 70069-481 Atropine Sulfate
Product NDC 70069-481
11-digit product format 700690481
Labeler code 70069
Product ID 70069-481_125328fe-c82b-42fd-bb3b-ba3f6c125ced
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atropine Sulfate monohydrate
Dosage form SOLUTION
Route ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Somerset Therapeutics, LLC
Application ANDA215005
Marketing category ANDA
Marketing start 2024-12-09
Substance ATROPINE SULFATE
Active strength .4 mg/mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215005-001 ATROPINE SULFATE ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL AP 2024-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215005-001 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 A215005-001 ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL AP 2024-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215005-001 ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL AP 2024-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215005-001 ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL AP 2024-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215005-001 ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL AP 2024-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215005-001 ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL AP 2024-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215005-001 ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL AP 2024-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215005-001 ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL AP 2024-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215005-001 ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL AP 2024-11-29 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215005-001 ATROPINE SULFATE 8MG/20ML (0.4MG/ML) SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL AP 2024-11-29 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Atropine Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATROPINE SULFATE .4 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 03J5ZE7KA5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1190776 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 70069-481-01 Atropine Sulfate 20 mL in 1 VIAL SOLUTION 20 3 70069-481-10 Atropine Sulfate 10 in 1 CARTON SOLUTION 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70069-481 ATROPINE SULFATE (ATROPINE SULFATE MONOHYDRATE) SOLUTION [SOMERSET THERAPEUTICS, LLC] 3 Current NDC, 2 package rows 20241215_84ba1689-3030-48d5-9cce-70b5a24a4033.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 70069-481-01 70069048101 20 mL in 1 VIAL 20 ml Historical 70069-481-10 70069048110 10 VIAL in 1 CARTON (70069-481-10) / 20 mL in 1 VIAL (70069-481-01) 10 vial 2024-12-09 No No Current