ATROPINE SULFATE

Product NDC
51662-1619
11-digit product format
516621619
Labeler code
51662
Product ID
51662-1619_100d196c-c853-3cf7-e063-6294a90ad8c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ATROPINE SULFATE
Dosage form
INJECTION
Route
ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA213561
Marketing category
ANDA
Marketing start
2022-10-01
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
e9fd624a-9abd-dfea-e053-2a95a90a8e9dAvailable 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
51662-1619-1ATROPINE SULFATE20 mL in 1 VIALINJECTION204
51662-1619-2ATROPINE SULFATE20 mL in 1 VIALINJECTION204
51662-1619-2ATROPINE SULFATE1 in 1 POUCHINJECTION14
51662-1619-3ATROPINE SULFATE10 in 1 CASEINJECTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1619ATROPINE SULFATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]4Current NDC, Legacy NDC, 4 package rows20240130_e9fd624a-9abd-dfea-e053-2a95a90a8e9d.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
ndc (product): 51662-1619
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLC0aab13de-04bf-2a14-e063-6294a90aae112023-11-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213561
application number: ANDA213561
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 SolutionPSNe9fd624a-9abd-dfea-e053-2a95a90a8e9d4
1190776atropine sulfate 0.4 MG/ML Injectable SolutionSCDe9fd624a-9abd-dfea-e053-2a95a90a8e9d4
1190776atropine sulfate 1 MG per 2.5 ML Injectable SolutionSYe9fd624a-9abd-dfea-e053-2a95a90a8e9d4
1190776atropine sulfate 1.2 MG per 3 ML Injectable SolutionSYe9fd624a-9abd-dfea-e053-2a95a90a8e9d4
1190776atropine sulfate 2 MG per 5 ML Injectable SolutionSYe9fd624a-9abd-dfea-e053-2a95a90a8e9d4
1190776atropine sulfate 8 MG per 20 ML Injectable SolutionSYe9fd624a-9abd-dfea-e053-2a95a90a8e9d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1619-15166216190120 mL in 1 VIAL (51662-1619-1) 20 ml2022-11-100000-00-00NoNoCurrent
51662-1619-25166216190220 mL in 1 VIAL20 mlHistorical
51662-1619-35166216190310 POUCH in 1 CASE (51662-1619-3) / 1 VIAL in 1 POUCH (51662-1619-2) / 20 mL in 1 VIAL10 pouch2022-10-010000-00-00NoNoCurrent