Home NDC 16729-526-03 Atropine Sulfate
Product NDC 16729-526
Requested package NDC 16729-526-03
11-digit product format 167290526
Labeler code 16729
Product ID 16729-526_d71ab6cc-d30f-32da-e053-2995a90aa7f6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ATROPINE SULFATE
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Accord Healthcare Inc.
Application NDA214652
Marketing category NDA
Marketing start 2021-01-11
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 16729-526 16729-526-03 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 78 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 2026-09-14 22:38:34 2026-08 N214652-001 ATROPINE SULFATE 0.4MG/ML (0.4MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214652-002 ATROPINE SULFATE 1MG/ML (1MG/ML) SOLUTION / INTRAVENOUS AP RLD 2020-09-29 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 59 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-526 ATROPINE SULFATE INJECTION, SOLUTION [ACCORD HEALTHCARE INC.] 6 Legacy NDC 20250302_d5e07279-48ca-4f83-9633-299e65a7f821.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16729-526-03 16729052603 10 VIAL, SINGLE-DOSE in 1 CARTON (16729-526-03) > 1 mL in 1 VIAL, SINGLE-DOSE 2022-10-06 0000-00-00 No No Current