Home NDC 16729-525-08 ATROPINE SULFATE
Product NDC 16729-525
Requested package NDC 16729-525-08
11-digit product format 167290525
Labeler code 16729
Product ID 16729-525_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 0 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 16729-525 16729-525-08 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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.
DailyMed Product Concepts# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-525 ATROPINE SULFATE INJECTION, SOLUTION [ACCORD HEALTHCARE INC.] 6 Legacy NDC 20250302_d5e07279-48ca-4f83-9633-299e65a7f821.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 Marketing end Sample Exclude flag Status 16729-525-08 16729052508 25 VIAL, SINGLE-DOSE in 1 CARTON (16729-525-08) > 1 mL in 1 VIAL, SINGLE-DOSE 2021-01-11 0000-00-00 No No Current