Home NDC 0409-1630-10 Atropine Sulfate
Product NDC 0409-1630
Requested package NDC 0409-1630-10
11-digit product format 004091630
Labeler code 0409
Product ID 0409-1630_3f33c683-46fb-40db-af0d-9211bc29d2a7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ATROPINE SULFATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Hospira, Inc.
Application NDA021146
Marketing category NDA
Marketing start 2006-01-19
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 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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021146-001 ATROPINE SULFATE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 N021146-002 ATROPINE SULFATE ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 N021146-003 ATROPINE SULFATE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 4 · 140 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 2026-02-19 14:30 UTC 2026-02 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021146-002 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021146-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 103 observed states.
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 .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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1190546 Internal RxNorm lookup 1190551 Internal RxNorm lookup 1190552 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 0409-1630-10 Atropine Sulfate 1 in 1 CARTON INJECTION, SOLUTION 1 31 0409-1630-10 Atropine Sulfate 10 in 1 PACKAGE INJECTION, SOLUTION 10 31 0409-1630-15 Atropine Sulfate 10 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 10 31
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATROPINE SULFATE ACTIVE INGREDIENT 03J5ZE7KA5 ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 ATROPINE ACTIVE MOIETY 7C0697DR9I ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 SULFURIC ACID INACTIVE INGREDIENT O40UQP6WCF ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 11 WATER INACTIVE INGREDIENT 059QF0KO0R ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-1630 ATROPINE SULFATE INJECTION, SOLUTION [HOSPIRA, INC.] 27 Current NDC, Legacy NDC, 3 package rows 20250124_ad8916e7-206e-409e-2582-30d072845dd4.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ATROPINE SULFATE ATROPINE SULFATE HF Acquisition Co LLC, DBA HealthFirst 768dc21a-b7d9-144c-e053-2991aa0af889 2026-06-19 Warnings, Adverse reactions Exact identifier application applno (NDA): 021146 application number: NDA021146 Atropine Sulfate ATROPINE SULFATE Hospira, Inc. ad8916e7-206e-409e-2582-30d072845dd4 2026-05-18 Warnings, Adverse reactions Exact identifier application applno (NDA): 021146 application number: NDA021146 ndc (package): 0409-1630-10 ndc (product): 0409-1630 ndc11 (package): 00409163010 Atropine Sulfate ATROPINE SULFATE Henry Schein, Inc. d4839e54-b350-4643-8e6e-f0437f5349d6 2025-04-17 Warnings, Adverse reactions Exact identifier application applno (NDA): 021146 application number: NDA021146 Atropine Sulfate ATROPINE SULFATE Medical Purchasing Solutions, LLC 66710a22-2eaa-6dbd-e053-2a91aa0a900d 2022-10-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 021146 application number: NDA021146
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0409-1630-10 00409163010 10 CARTON in 1 PACKAGE (0409-1630-10) / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC (0409-1630-15) 10 carton 2006-01-19 0000-00-00 No No Current