ATROPINE SULFATE

Product NDC
71872-7298
Requested package NDC
71872-7298-1
11-digit product format
718727298
Labeler code
71872
Product ID
71872-7298_fa1c8b84-5f06-0df2-e053-6294a90abc11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA212868
Marketing category
ANDA
Marketing start
2021-07-30
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
A212868-001ATROPINE SULFATEATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26
A212868-002ATROPINE SULFATEATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26
A212868-003ATROPINE SULFATEATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212868-001AP
A212868-002AP
A212868-003AP

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 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212868-002ATROPINE SULFATE0.5MG/5ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212868-003ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2021-07-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212868-001ATROPINE SULFATE0.25MG/5ML (0.05MG/ML)SOLUTION / INTRAVENOUSAP2021-07-268072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212868-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212868-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212868-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212868-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212868-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212868-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212868-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212868-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212868-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212868-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212868-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212868-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212868-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212868-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212868-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212868-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212868-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212868-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212868-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212868-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212868-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212868-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212868-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212868-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212868-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212868-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212868-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212868-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212868-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A212868-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212868-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212868-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212868-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212868-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212868-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212868-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212868-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212868-002AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212868-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212868-001AP18072bd15b7f6…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212868-001CGT2022-01-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212868-002CGT2022-01-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212868-003CGT2022-01-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212868-001CGT2022-01-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212868-002CGT2022-01-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A212868-003CGT2022-01-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212868-001CGT2022-01-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212868-002CGT2022-01-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A212868-003CGT2022-01-264b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212868-001CGT2022-01-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212868-002CGT2022-01-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A212868-003CGT2022-01-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212868-001CGT2022-01-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A212868-002CGT2022-01-26782e0a99824c…
2021-12-28 21:50 UTC2021-12A212868-003CGT2022-01-26782e0a99824c…
2023-01-26 05:58 UTC2023-01A212868-001CGT2022-01-263bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A212868-002CGT2022-01-263bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A212868-003CGT2022-01-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212868-001CGT2022-01-263a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212868-002CGT2022-01-263a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212868-003CGT2022-01-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212868-001CGT2022-01-26f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A212868-002CGT2022-01-26f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A212868-003CGT2022-01-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212868-001CGT2022-01-26e64feba35796…
2022-09-29 23:25 UTC2022-09A212868-002CGT2022-01-26e64feba35796…
2022-09-29 23:25 UTC2022-09A212868-003CGT2022-01-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212868-001CGT2022-01-26cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212868-002CGT2022-01-26cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212868-003CGT2022-01-26cb3db0bc1861…

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
fa1c953b-723b-1abe-e053-6394a90a967fAvailable 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
71872-7298-1ATROPINE SULFATE10 mL in 1 SYRINGE, GLASSINJECTION101
71872-7298-1ATROPINE SULFATE1 in 1 BAGINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7298ATROPINE SULFATE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]1Current NDC, 2 package rows20230425_fa1c953b-723b-1abe-e053-6394a90a967f.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATROPINE SULFATEATROPINE SULFATEAccord Healthcare, Inc.,c82cb295-ffce-47d6-97ad-a8aa723f4e4f2025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212868
application number: ANDA212868
ATROPINE SULFATEATROPINE SULFATEMedical Purchasing Solutions, LLCfa1c953b-723b-1abe-e053-6394a90a967f2023-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212868
application number: ANDA212868
ndc (package): 71872-7298-1
ndc (product): 71872-7298
ndc11 (package): 71872729801

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSNfa1c953b-723b-1abe-e053-6394a90a967f1
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCDfa1c953b-723b-1abe-e053-6394a90a967f1
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSYfa1c953b-723b-1abe-e053-6394a90a967f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71872-7298-1718727298011 SYRINGE, GLASS in 1 BAG (71872-7298-1) / 10 mL in 1 SYRINGE, GLASS2022-08-08NoNoCurrent