Home NDC 71053-592-01 N/A
Product NDC 71053-592
Requested package NDC 71053-592-01
11-digit product format 710530592
Labeler code 71053
Product ID 71053-592_4b1cda4c-c117-7a42-e063-6294a90a14e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atropine Injection, 2 mg
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Rafa Laboratories, Ltd.
Application NDA212319
Marketing category NDA
Marketing start 2018-07-09
Substance ATROPINE
Active strength 2 mg/.7mL
Pharmacologic classes Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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 N212319-001 ATROPINE (AUTOINJECTOR) ATROPINE EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09
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 · 41 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 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212319-001 ATROPINE (AUTOINJECTOR) EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) SOLUTION / INTRAMUSCULAR 2018-07-09 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATROPINE 2 mg/.7mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7C0697DR9I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1190538 Internal RxNorm lookup 1190540 Internal RxNorm lookup 1190542 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71053-592-01 N/A 40 in 1 CARTON INJECTION 40 8 71053-592-01 N/A 480 in 1 BOX INJECTION 480 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71053-592 N/A (ATROPINE SULFATE INJECTION USP, 1 MG/0.7 ML) INJECTION N/A (ATROPINE SULFATE INJECTION USP, 0.5 MG/0.7 ML) INJECTION N/A (ATROPINE INJECTION, 2 MG) INJECTION [RAFA LABORATORIES, LTD.] 7 Current NDC, Legacy NDC, 2 package rows 20240807_4a4fa6e8-0e0a-0e76-e054-00144ff8d46c.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 Units Marketing start Marketing end Sample Exclude flag Status 71053-592-01 71053059201 480 CARTON in 1 BOX (71053-592-01) / 40 SYRINGE in 1 CARTON / .7 mL in 1 SYRINGE 480 carton 2018-07-09 0000-00-00 No No Current