Home NDC 64253-400-91 Atropine Sulfate
Product NDC 64253-400
Requested package NDC 64253-400-91
11-digit product format 642530400
Labeler code 64253
Product ID 64253-400_46a6a31f-46ab-a437-e063-6394a90a4ad0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atropine Sulfate Injection
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Medefil, Inc.
Application ANDA214970
Marketing category ANDA
Marketing start 2023-05-11
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214970-001 ATROPINE SULFATE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214970-001 AP
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.
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 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 3a93d1ddd44b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214970-001 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-11-04 a50c72e98297…
Observed Orange Book normalized TE 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 · 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 64253-400-30 Atropine Sulfate 10 mL in 1 SYRINGE, PLASTIC INJECTION, SOLUTION 10 2 64253-400-91 Atropine Sulfate 10 in 1 BOX INJECTION, SOLUTION 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64253-400 ATROPINE SULFATE (ATROPINE SULFATE INJECTION) INJECTION, SOLUTION [MEDEFIL, INC.] 1 Current NDC, 2 package rows 20230528_fbfdf718-befe-ad22-e053-6294a90a3715.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 Sample Exclude flag Status 64253-400-91 64253040091 10 SYRINGE, PLASTIC in 1 BOX (64253-400-91) / 10 mL in 1 SYRINGE, PLASTIC (64253-400-30) 2023-05-11 No No Current