Home NDC 16729-484-90 ATROPINE SULFATE
Product NDC 16729-484
Requested package NDC 16729-484-90
11-digit product format 167290484
Labeler code 16729
Product ID 16729-484_4082a1cf-1e1b-6f40-e063-6294a90aec06
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ATROPINE SULFATE
Dosage form INJECTION
Route INTRAVENOUS
Labeler Accord Healthcare, Inc.,
Application ANDA212868
Marketing category ANDA
Marketing start 2021-07-30
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 A212868-001 ATROPINE SULFATE ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 A212868-002 ATROPINE SULFATE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 A212868-003 ATROPINE SULFATE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26
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 3 · 99 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 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212868-002 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212868-003 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212868-001 ATROPINE SULFATE 0.25MG/5ML (0.05MG/ML) SOLUTION / INTRAVENOUS AP 2021-07-26 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 99 observed states.
Observed Orange Book exclusivity history# 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 · 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 16729-484-03 ATROPINE SULFATE 10 mL in 1 SYRINGE, GLASS INJECTION 10 9 16729-484-31 ATROPINE SULFATE 5 mL in 1 SYRINGE, GLASS INJECTION 5 9 16729-484-45 ATROPINE SULFATE 10 mL in 1 SYRINGE, GLASS INJECTION 10 9 16729-484-45 ATROPINE SULFATE 10 in 1 CARTON INJECTION 10 9 16729-484-90 ATROPINE SULFATE 10 in 1 CARTON INJECTION 10 9 16729-484-90 ATROPINE SULFATE 5 mL in 1 SYRINGE, GLASS INJECTION 5 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-484 ATROPINE SULFATE INJECTION [ACCORD HEALTHCARE, INC.,] 8 Current NDC, Legacy NDC, 6 package rows 20241122_c82cb295-ffce-47d6-97ad-a8aa723f4e4f.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 · 2 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 16729-484-90 16729048490 10 SYRINGE, GLASS in 1 CARTON (16729-484-90) / 5 mL in 1 SYRINGE, GLASS 2021-08-19 0000-00-00 No No Current