Atropine Sulfate

Product NDC
71872-7245
Requested package NDC
71872-7245-1
11-digit product format
718727245
Labeler code
71872
Product ID
71872-7245_eaef17bc-bf14-6157-e053-2a95a90a3910
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
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71872-724571872-7245-1EExcluded 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 1 of 2 · 59 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N214652-001AP184e616aacf4f…
2026-09-14 22:38:342026-08N214652-002AP184e616aacf4f…
2026-08-18 06:07:402026-07N214652-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N214652-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N214652-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N214652-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N214652-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N214652-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214652-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N214652-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214652-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N214652-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214652-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N214652-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214652-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N214652-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214652-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N214652-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214652-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N214652-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N214652-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N214652-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214652-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N214652-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214652-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N214652-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214652-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N214652-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N214652-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N214652-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214652-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N214652-002AP15c6f7cd8ea54…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214652-001AP16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N214652-002AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N214652-001AP11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N214652-002AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N214652-001AP1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N214652-002AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214652-001AP1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N214652-002AP1a72a2bbeb626…

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
71872-7245-1Atropine Sulfate1 in 1 BAGINJECTION, SOLUTION12
71872-7245-1Atropine Sulfate1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7245ATROPINE SULFATE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]2Legacy NDC, 2 package rows20221014_bfc8a727-0cb8-3152-e053-2995a90a28ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190795atropine sulfate 1 MG in 1 ML InjectionPSNbfc8a727-0cb8-3152-e053-2995a90a28ba2
11907951 ML atropine sulfate 1 MG/ML InjectionSCDbfc8a727-0cb8-3152-e053-2995a90a28ba2
1190795atropine sulfate 1 MG per 1 ML InjectionSYbfc8a727-0cb8-3152-e053-2995a90a28ba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71872-7245-1718727245011 VIAL, SINGLE-DOSE in 1 BAG (71872-7245-1) > 1 mL in 1 VIAL, SINGLE-DOSE2021-03-300000-00-00NoNoCurrent