Atropine Sulfate

Product NDC
76329-3340
11-digit product format
763293340
Labeler code
76329
Product ID
76329-3340_697aa53c-f31f-463a-a752-d2faaad354db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
International Medication Systems, Limited
Application
ANDA212461
Marketing category
ANDA
Marketing start
2021-02-17
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212461-001ATROPINE SULFATEATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212461-001AP

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
2026-02-19 14:30 UTC2026-02A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-054b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAA2020-10-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAA2020-10-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAA2020-10-05c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212461-001ATROPINE SULFATE1MG/10ML (0.1MG/ML)SOLUTION / INTRAVENOUSAP2020-10-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212461-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212461-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212461-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212461-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212461-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212461-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212461-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212461-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212461-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212461-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212461-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212461-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212461-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212461-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212461-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212461-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212461-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212461-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212461-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212461-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A212461-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212461-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212461-001AA1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212461-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212461-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212461-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212461-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212461-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212461-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212461-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212461-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212461-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212461-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212461-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212461-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212461-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212461-001AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATROPINE SULFATE.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
b72d0a82-6163-460f-965a-12f6da47370aAvailable 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
76329-3340-1Atropine Sulfate1 in 1 CARTONINJECTION16
76329-3340-1Atropine Sulfate10 in 1 PACKAGEINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76329-3340-1ML - Milliliter76329-33408f766000-ede3-4e9c-892b-01f7fdf4b35a12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76329-3340ATROPINE SULFATE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED]6Current NDC, Legacy NDC, 2 package rows20250207_b72d0a82-6163-460f-965a-12f6da47370a.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.46ba6000-b842-449a-8dd4-7bb9dc7a74c52026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212461
application number: ANDA212461
Atropine SulfateATROPINE SULFATEA-S Medication Solutions739f384f-1a69-4953-93a0-aa6a76de0ecc2026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212461
application number: ANDA212461
Atropine SulfateATROPINE SULFATEProPharma Distribution3d5c747f-3bf7-2597-e063-6394a90a828c2025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212461
application number: ANDA212461
Atropine SulfateATROPINE SULFATEInternational Medication Systems, Limitedb72d0a82-6163-460f-965a-12f6da47370a2025-01-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212461
application number: ANDA212461
ndc (product): 76329-3340
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstc0d0ca2a-4267-41b7-e053-2a95a90a47262024-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212461
application number: ANDA212461
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLCc434062a-cd44-e684-e053-2995a90a91c32023-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212461
application number: ANDA212461

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSN46ba6000-b842-449a-8dd4-7bb9dc7a74c56
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSN739f384f-1a69-4953-93a0-aa6a76de0ecc6
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSNb72d0a82-6163-460f-965a-12f6da47370a6
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCD46ba6000-b842-449a-8dd4-7bb9dc7a74c56
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCD739f384f-1a69-4953-93a0-aa6a76de0ecc6
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCDb72d0a82-6163-460f-965a-12f6da47370a6
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSY46ba6000-b842-449a-8dd4-7bb9dc7a74c56
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSY739f384f-1a69-4953-93a0-aa6a76de0ecc6
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSYb72d0a82-6163-460f-965a-12f6da47370a6
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSNc0d0ca2a-4267-41b7-e053-2a95a90a47263
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCDc0d0ca2a-4267-41b7-e053-2a95a90a47263
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSYc0d0ca2a-4267-41b7-e053-2a95a90a47263
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSN3d5c747f-3bf7-2597-e063-6394a90a828c2
1190546atropine sulfate 1 MG in 10 ML Prefilled SyringePSNc434062a-cd44-e684-e053-2995a90a91c32
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCDc434062a-cd44-e684-e053-2995a90a91c32
119054610 ML atropine sulfate 0.1 MG/ML Prefilled SyringeSCD3d5c747f-3bf7-2597-e063-6394a90a828c2
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSY3d5c747f-3bf7-2597-e063-6394a90a828c2
1190546atropine sulfate 1 MG per 10 ML Prefilled SyringeSYc434062a-cd44-e684-e053-2995a90a91c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76329-3340-17632933400110 CARTON in 1 PACKAGE (76329-3340-1) / 1 SYRINGE in 1 CARTON / 10 mL in 1 SYRINGE10 carton2021-02-170000-00-00NoNoCurrent