Home NDC 0404-9802 Atropine Sulfate
Product NDC 0404-9802
11-digit product format 004049802
Labeler code 0404
Product ID 0404-9802_9bb95512-44d0-401e-9730-b926017a1130
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atropine Sulfate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Henry Schein, Inc
Application ANDA216120
Marketing category ANDA
Marketing start 2024-08-22
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216120-001 ATROPINE SULFATE ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RS 2022-05-26 A216120-002 ATROPINE SULFATE ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RS 2022-05-26
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.
Product history page 1 of 2 · 64 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 2026-10-15 13:18:30 2026-09 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RS 2022-05-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RS 2022-05-26 c2088c7a36db…2026-09-14 22:38:34 2026-08 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RS 2022-05-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RS 2022-05-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RS 2022-05-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RS 2022-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RS 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RS 2022-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RS 2022-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RS 2022-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216120-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216120-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP 2022-05-26 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 64 observed states.
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Atropine Sulfate
Listing expiration 2027-12-31 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 1666781 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 0404-9802-01 Atropine Sulfate 1 mL in 1 VIAL, GLASS INJECTION, SOLUTION 1 2 0404-9802-01 Atropine Sulfate 1 in 1 BAG INJECTION, SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9802 ATROPINE SULFATE INJECTION, SOLUTION [HENRY SCHEIN, INC] 1 Current NDC, 2 package rows 20240828_b753894e-81f8-4e81-b07a-c338311ded5b.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Atropine Sulfate ATROPINE SULFATE ProPharma Distribution 3ef1a1a0-93c1-e6b6-e063-6294a90aa2b6 2025-09-17 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216120 application number: ANDA216120 ATROPINE SULFATE ATROPINE SULFATE HF Acquisition Co LLC, DBA HealthFirst 0060b971-19bd-2849-e063-6294a90afca8 2024-01-28 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216120 application number: ANDA216120 Atropine sulfate ATROPINE SULFATE HF Acquisition Co LLC, DBA HealthFirst 007728fc-f4cb-d519-e063-6394a90ae033 2024-01-22 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216120 application number: ANDA216120 Atropine Sulfate ATROPINE SULFATE Medical Purchasing Solutions, LLC 09d086f2-db9a-5e15-e063-6394a90abe18 2023-11-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216120 application number: ANDA216120 Atropine Sulfate ATROPINE SULFATE American Regent, Inc. 6fee1727-52b7-4f73-ab45-ef47d6a1c5bb 2021-09-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216120 application number: ANDA216120
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0404-9802-01 00404980201 1 VIAL, GLASS in 1 BAG (0404-9802-01) / 1 mL in 1 VIAL, GLASS 2024-08-22 No No Current