Atropine Sulfate

Product NDC
71872-7316
Requested package NDC
71872-7316-1
11-digit product format
718727316
Labeler code
71872
Product ID
71872-7316_0aab02be-9f0a-1b7f-e063-6294a90a7011
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
INJECTION
Route
ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Medical Purchasing Solutions, LLC
Application
ANDA213561
Marketing category
ANDA
Marketing start
2021-12-01
Substance
ATROPINE SULFATE
Active strength
.4 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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213561-001ATROPINE SULFATEATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213561-001AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-014b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-013f0d92c62455…
2023-05-13 08:27 UTC2023-05A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01053a50430f4f…
2023-01-26 05:58 UTC2023-01A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213561-001ATROPINE SULFATE8MG/20ML (0.4MG/ML)SOLUTION / INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEALAP2021-12-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213561-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213561-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213561-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213561-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213561-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213561-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213561-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213561-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213561-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213561-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213561-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213561-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213561-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213561-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213561-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213561-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213561-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213561-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213561-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213561-001AP1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213561-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213561-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213561-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213561-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213561-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213561-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213561-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213561-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A213561-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213561-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213561-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213561-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213561-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213561-001AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.4 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
1190776Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0aab13de-04bf-2a14-e063-6294a90aae11Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71872-7316-1Atropine Sulfate20 mL in 1 VIALINJECTION201
71872-7316-1Atropine Sulfate1 in 1 BAGINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71872-7316ATROPINE SULFATE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC]1Current NDC, 2 package rows20231122_0aab13de-04bf-2a14-e063-6294a90aae11.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 SULFATEREMEDYREPACK INC.8663ff94-8bea-4061-9fd5-3ab2e85e862e2025-10-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213561
application number: ANDA213561
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirste9fd624a-9abd-dfea-e053-2a95a90a8e9d2024-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213561
application number: ANDA213561
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLC0aab13de-04bf-2a14-e063-6294a90aae112023-11-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213561
application number: ANDA213561
ndc (package): 71872-7316-1
ndc (product): 71872-7316
ndc11 (package): 71872731601
Atropine SulfateATROPINE SULFATEHikma Pharmaceuticals USA Inc.4c15d3cc-7888-4c82-b3f8-a5d93c5523df2023-01-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213561
application number: ANDA213561

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190776atropine sulfate 0.4 MG/ML Injectable SolutionPSN0aab13de-04bf-2a14-e063-6294a90aae111
1190776atropine sulfate 0.4 MG/ML Injectable SolutionSCD0aab13de-04bf-2a14-e063-6294a90aae111
1190776atropine sulfate 1 MG per 2.5 ML Injectable SolutionSY0aab13de-04bf-2a14-e063-6294a90aae111
1190776atropine sulfate 1.2 MG per 3 ML Injectable SolutionSY0aab13de-04bf-2a14-e063-6294a90aae111
1190776atropine sulfate 2 MG per 5 ML Injectable SolutionSY0aab13de-04bf-2a14-e063-6294a90aae111
1190776atropine sulfate 8 MG per 20 ML Injectable SolutionSY0aab13de-04bf-2a14-e063-6294a90aae111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71872-7316-1718727316011 VIAL in 1 BAG (71872-7316-1) / 20 mL in 1 VIAL1 vial2023-10-19NoNoCurrent