FDA.reportPublic FDA data

Atropine Sulfate

Product NDC
0641-6251
11-digit product format
006416251
Labeler code
0641
Product ID
0641-6251_f5ca4281-8c89-4efc-80b1-2fbcf61c7c55
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
INJECTION
Route
ENDOTRACHEAL; INTRAMEDULLARY; INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
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

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 Identifiers#

Field, Values table
FieldValues
Unii03J5ZE7KA5
Rxcui1190776

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
0641-6251-10Atropine Sulfate20 mL in 1 VIALINJECTION203
0641-6251-10Atropine Sulfate10 in 1 CARTONINJECTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6251-10ML - Milliliter0641-62516548b8f4-cd96-4e6e-ba23-efe63d5bfa4212022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6251ATROPINE SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20240410_4c15d3cc-7888-4c82-b3f8-a5d93c5523df.zip

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
1190776atropine sulfate 0.4 MG/ML Injectable SolutionPSN4c15d3cc-7888-4c82-b3f8-a5d93c5523df3
1190776atropine sulfate 0.4 MG/ML Injectable SolutionSCD4c15d3cc-7888-4c82-b3f8-a5d93c5523df3
1190776atropine sulfate 1 MG per 2.5 ML Injectable SolutionSY4c15d3cc-7888-4c82-b3f8-a5d93c5523df3
1190776atropine sulfate 1.2 MG per 3 ML Injectable SolutionSY4c15d3cc-7888-4c82-b3f8-a5d93c5523df3
1190776atropine sulfate 2 MG per 5 ML Injectable SolutionSY4c15d3cc-7888-4c82-b3f8-a5d93c5523df3
1190776atropine sulfate 8 MG per 20 ML Injectable SolutionSY4c15d3cc-7888-4c82-b3f8-a5d93c5523df3
1190776atropine sulfate 0.4 MG/ML Injectable SolutionPSN8663ff94-8bea-4061-9fd5-3ab2e85e862e2
1190776atropine sulfate 0.4 MG/ML Injectable SolutionSCD8663ff94-8bea-4061-9fd5-3ab2e85e862e2
1190776atropine sulfate 1 MG per 2.5 ML Injectable SolutionSY8663ff94-8bea-4061-9fd5-3ab2e85e862e2
1190776atropine sulfate 1.2 MG per 3 ML Injectable SolutionSY8663ff94-8bea-4061-9fd5-3ab2e85e862e2
1190776atropine sulfate 2 MG per 5 ML Injectable SolutionSY8663ff94-8bea-4061-9fd5-3ab2e85e862e2
1190776atropine sulfate 8 MG per 20 ML Injectable SolutionSY8663ff94-8bea-4061-9fd5-3ab2e85e862e2
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 startMarketing endSampleExclude flagStatus
0641-6251-100064162511010 VIAL in 1 CARTON (0641-6251-10) / 20 mL in 1 VIAL10 vial2021-12-010000-00-00NoNoCurrent