Home NDC 70121-1706-2 atropine sulfate
Product NDC 70121-1706
Requested package NDC 70121-1706-2
11-digit product format 701211706
Labeler code 70121
Product ID 70121-1706_cd6e7dcc-16d0-4663-859e-c22fe300a536
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name atropine sulfate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application ANDA215342
Marketing category ANDA
Marketing start 2024-01-09
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215342-001 ATROPINE SULFATE ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 A215342-002 ATROPINE SULFATE ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 51 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215342-001 ATROPINE SULFATE 0.5MG/5ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2022-01-26 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215342-002 ATROPINE SULFATE 1MG/10ML (0.1MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-25 a72a2bbeb626…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 51 observed states.
Additional Listing Data#
Finished product Yes
Brand name base atropine sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATROPINE SULFATE .1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 03J5ZE7KA5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1190546 Internal RxNorm lookup 1190552 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70121-1706-1 atropine sulfate 10 mL in 1 SYRINGE, GLASS INJECTION, SOLUTION 10 12 70121-1706-1 atropine sulfate 1 in 1 CARTON INJECTION, SOLUTION 1 12 70121-1706-2 atropine sulfate 5 in 1 TRAY INJECTION, SOLUTION 5 12 70121-1706-2 atropine sulfate 10 in 1 CARTON INJECTION, SOLUTION 10 12 70121-1706-4 atropine sulfate 24 in 1 PACKAGE INJECTION, SOLUTION 24 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-1706 ATROPINE SULFATE INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC] 10 Current NDC, 5 package rows 20240920_80a31286-a741-4440-b200-290c08925d06.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70121-1706-2 70121170602 10 TRAY in 1 CARTON (70121-1706-2) / 5 SYRINGE, GLASS in 1 TRAY / 10 mL in 1 SYRINGE, GLASS 10 tray 2024-01-09 No No Current