ATROPINE SULFATE

Product NDC
71872-7246
11-digit product format
718727246
Labeler code
71872
Product ID
71872-7246_bfc9895b-5bfa-28c1-e053-2a95a90a7a73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
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
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71872-7246EExcluded after deficient or non-compliant submission was not corrected2026-10-05
excluded packagepackage71872-724671872-7246-1EExcluded after deficient or non-compliant submission was not corrected2026-10-05

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N214652-001ATROPINE SULFATEATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD2020-09-29
N214652-002ATROPINE SULFATEATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD2020-09-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N214652-001AP
N214652-002AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD2020-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD2020-09-2984e616aacf4f…
2026-08-18 06:07:402026-07N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD2020-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD2020-09-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSRLD2020-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD2020-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSRLD2020-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD2020-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2020-09-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-09-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-09-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-09-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-09-294b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N214652-001ATROPINE SULFATE0.4MG/ML (0.4MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-09-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N214652-002ATROPINE SULFATE1MG/ML (1MG/ML)SOLUTION / INTRAVENOUSRLD, RS2020-09-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 59 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N214652-001AP19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N214652-002AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N214652-001AP1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N214652-002AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N214652-001AP13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N214652-002AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N214652-001AP1053a50430f4f…
2023-05-13 08:27 UTC2023-05N214652-002AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N214652-001AP13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N214652-002AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N214652-001AP13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N214652-002AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N214652-001AP1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N214652-002AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N214652-001AP1e64feba35796…
2022-09-29 23:25 UTC2022-09N214652-002AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N214652-001AP1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N214652-002AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N214652-002AP1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7246-1ATROPINE SULFATE1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12
71872-7246-1ATROPINE SULFATE1 in 1 BAGINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7246ATROPINE SULFATE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Legacy NDC, 2 package rows20230429_bfc93de4-f731-31fa-e053-2a95a90aadcb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666781atropine sulfate 0.4 MG in 1 ML InjectionPSNbfc93de4-f731-31fa-e053-2a95a90aadcb2
16667811 ML atropine sulfate 0.4 MG/ML InjectionSCDbfc93de4-f731-31fa-e053-2a95a90aadcb2
1666781atropine sulfate 0.4 MG per 1 ML InjectionSYbfc93de4-f731-31fa-e053-2a95a90aadcb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7246-1718727246011 VIAL, SINGLE-DOSE in 1 BAG (71872-7246-1) > 1 mL in 1 VIAL, SINGLE-DOSE2021-03-300000-00-00NoNoCurrent