Atropine

Product NDC
13985-606
11-digit product format
139850606
Labeler code
13985
Product ID
13985-606_d2f70a87-b14f-48da-9a18-84f8cedbe6c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atropine Sulfate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
MWI
Application
NDA206289
Marketing category
NDA
Marketing start
2015-03-23
Marketing end
0000-00-00
Substance
ATROPINE SULFATE
Active strength
10 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct13985-606IInactivated by FDA2026-08-11
excluded packagepackage13985-60613985-606-05IInactivated by FDA2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage13985-606-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage13985-606-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage13985-606-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage13985-606-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage13985-606-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage13985-606-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage13985-606-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage13985-606-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage13985-606-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage13985-606-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage13985-606-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage13985-606-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage13985-606-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage13985-606-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage13985-606-051332a3947898…d4bfe170f9cd…

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
N206289-001ATROPINE SULFATEATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N206289-001AT1

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICAT1RLD2014-07-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICRLD, RS2014-07-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICRLD, RS2014-07-1887673890dc5c…
2021-03-12 10:30 UTC2021-03N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICRLD, RS2014-07-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICRLD, RS2014-07-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICRLD, RS2014-07-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICRLD, RS2014-07-183f01610625f2…
2019-09-15 20:21 UTC2019-09N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICRLD, RS2014-07-18b00525d2431f…
2019-07-19 19:46 UTC2019-07N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICRLD, RS2014-07-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD2014-07-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD2014-07-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD2014-07-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD2014-07-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD2014-07-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-183f0d92c62455…
2023-05-13 08:27 UTC2023-05N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-18053a50430f4f…
2023-01-26 05:58 UTC2023-01N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N206289-001ATROPINE SULFATE1%SOLUTION/DROPS / OPHTHALMICATRLD, RS2014-07-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N206289-001AT11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206289-001AT1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N206289-001AT116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206289-001AT11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206289-001AT11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206289-001AT1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206289-001AT112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206289-001AT115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206289-001AT11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206289-001AT11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206289-001AT1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206289-001AT11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206289-001AT111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206289-001AT118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206289-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206289-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206289-001AT14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N206289-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N206289-001AT1782e0a99824c…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206289-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N206289-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N206289-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206289-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206289-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206289-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N206289-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N206289-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N206289-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N206289-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N206289-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206289-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N206289-001AT1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206289-001AT11a50c72e98297…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13985-606-05Atropine1 in 1 CARTONSOLUTION/ DROPS14
13985-606-05Atropine5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS54

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atropine SulfateACTIVE INGREDIENT03J5ZE7KA5ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
AtropineACTIVE MOIETY7C0697DR9IATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Hypromellose 2910 (4000 MPA.S)INACTIVE INGREDIENTRN3152OP35ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
Sodium Phosphate, MonobasicINACTIVE INGREDIENT3980JIH2SWATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1
WaterINACTIVE INGREDIENT059QF0KO0RATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13985-606ATROPINE (ATROPINE SULFATE) SOLUTION/ DROPS [MWI]4Legacy NDC, 2 package rows20220520_590a4e7b-565f-415f-a8e4-499a382c9a3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190655atropine sulfate 1 % Ophthalmic SolutionPSN590a4e7b-565f-415f-a8e4-499a382c9a3b4
1190655atropine sulfate 10 MG/ML Ophthalmic SolutionSCD590a4e7b-565f-415f-a8e4-499a382c9a3b4
1190655atropine sulfate 1 % Ophthalmic SolutionSY590a4e7b-565f-415f-a8e4-499a382c9a3b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13985-606-05139850606051 BOTTLE, DROPPER in 1 CARTON (13985-606-05) > 5 mL in 1 BOTTLE, DROPPER2015-03-230000-00-00NoNoCurrent