Home NDC 51662-1289-3 ATROPINE SULFATE
Product NDC 51662-1289
Requested package NDC 51662-1289-3
11-digit product format 516621289
Labeler code 51662
Product ID 51662-1289_1250f9a9-93b2-a4c1-e063-6394a90a7b36
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ATROPINE SULFATE
Dosage form INJECTION, SOLUTION
Route ENDOTRACHEAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler HF Acquisition Co LLC, DBA HealthFirst
Application NDA021146
Marketing category NDA
Marketing start 2018-09-23
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 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SULFATE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 N021146-002 ATROPINE SULFATE ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML)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N021146-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION / INTRAVENOUS AP RLD, RS 2001-07-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021146-002 ATROPINE SULFATE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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1190546 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 51662-1289-1 ATROPINE SULFATE 1 in 1 CARTON INJECTION, SOLUTION 1 10 51662-1289-1 ATROPINE SULFATE 10 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 10 10 51662-1289-2 ATROPINE SULFATE 1 in 1 CARTON INJECTION, SOLUTION 1 10 51662-1289-2 ATROPINE SULFATE 1 in 1 POUCH INJECTION, SOLUTION 1 10 51662-1289-3 ATROPINE SULFATE 10 in 1 CASE INJECTION, SOLUTION 10 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51662-1289 ATROPINE SULFATE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] 10 Current NDC, Legacy NDC, 5 package rows 20240228_768dc21a-b7d9-144c-e053-2991aa0af889.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 ndc (package): 51662-1289-3 ndc (product): 51662-1289 ndc11 (package): 51662128903 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 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 51662-1289-3 51662128903 10 POUCH in 1 CASE (51662-1289-3) / 1 CARTON in 1 POUCH (51662-1289-2) / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC 10 pouch 2022-12-12 0000-00-00 No No Current