Home NDC 0404-9989-01 Atropine Sulfate
Product NDC 0404-9989
Requested package NDC 0404-9989-01
11-digit product format 004049989
Labeler code 0404
Product ID 0404-9989_edaf1d42-c2af-4369-8d75-b3a93d70d390
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atropine Sulfate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Henry Schein, Inc.
Application NDA214652
Marketing category NDA
Marketing start 2023-09-05
Substance ATROPINE SULFATE
Active strength 1 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214652-001 ATROPINE SULFATE ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29 N214652-002 ATROPINE SULFATE ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29
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 · 76 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 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS RLD 2020-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS RLD 2020-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2020-09-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2020-09-29 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 57 observed states.
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 1 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 1190795 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 0404-9989-01 Atropine Sulfate 1 in 1 BAG INJECTION, SOLUTION 1 3 0404-9989-01 Atropine Sulfate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9989 ATROPINE SULFATE INJECTION, SOLUTION [HENRY SCHEIN, INC.] 3 Current NDC, 2 package rows 20250119_4a9559e8-7a34-4509-a8cc-ff0125694539.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 Sample Exclude flag Status 0404-9989-01 00404998901 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9989-01) / 1 mL in 1 VIAL, SINGLE-DOSE 2023-09-12 No No Current