Atropine Sulfate

Product NDC
71872-7002
Requested package NDC
71872-7002-1
11-digit product format
718727002
Labeler code
71872
Product ID
71872-7002_eaee9ea4-7c4b-26ce-e053-2995a90acdd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION, SOLUTION
Route
ENDOTRACHEAL; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Medical Purchasing Solutions, LLC
Application
NDA021146
Marketing category
NDA
Marketing start
2006-01-19
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021146-001ATROPINE SULFATEATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09
N021146-002ATROPINE SULFATEATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09
N021146-003ATROPINE SULFATEATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N021146-001AP
N021146-002AP
N021146-003AP

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 4 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09d06236e962d9…
2024-10-29 15:01 UTC2024-10N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021146-002ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021146-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAPRLD, RS2001-07-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021146-001ATROPINE SULFATE0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / INTRAVENOUSAPRLD, RS2001-07-098072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 103 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021146-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021146-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021146-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021146-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021146-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021146-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021146-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021146-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021146-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021146-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021146-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021146-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021146-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021146-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021146-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021146-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021146-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021146-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021146-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021146-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021146-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021146-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021146-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021146-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021146-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021146-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021146-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021146-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021146-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021146-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021146-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021146-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021146-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021146-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021146-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021146-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021146-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021146-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021146-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021146-001AP18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Atropine Sulfate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
03J5ZE7KA5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1190546Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
66710a22-2eaa-6dbd-e053-2a91aa0a900dAvailable on FDA.report

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
71872-7002-1Atropine Sulfate1 in 1 CARTONINJECTION, SOLUTION14
71872-7002-1Atropine Sulfate10 in 1 BAGINJECTION, SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7002ATROPINE SULFATE INJECTION, SOLUTION [MEDICAL PURCHASING SOLUTIONS, LLC]4Current NDC, Legacy NDC, 2 package rows20221014_66710a22-2eaa-6dbd-e053-2a91aa0a900d.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirst768dc21a-b7d9-144c-e053-2991aa0af8892026-06-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 021146
application number: NDA021146
Atropine SulfateATROPINE SULFATEHospira, Inc.ad8916e7-206e-409e-2582-30d072845dd42026-05-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 021146
application number: NDA021146
Atropine SulfateATROPINE SULFATEHenry Schein, Inc.d4839e54-b350-4643-8e6e-f0437f5349d62025-04-17Warnings, Adverse reactionsExact identifier
application applno (NDA): 021146
application number: NDA021146
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLC66710a22-2eaa-6dbd-e053-2a91aa0a900d2022-10-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 021146
application number: NDA021146
ndc (package): 71872-7002-1
ndc (product): 71872-7002
ndc11 (package): 71872700201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSN66710a22-2eaa-6dbd-e053-2a91aa0a900d4
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCD66710a22-2eaa-6dbd-e053-2a91aa0a900d4
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSY66710a22-2eaa-6dbd-e053-2a91aa0a900d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71872-7002-17187270020110 CARTON in 1 BAG (71872-7002-1) / 1 SYRINGE, PLASTIC in 1 CARTON / 10 mL in 1 SYRINGE, PLASTIC10 carton2018-02-280000-00-00NoNoCurrent