ATROPEN Auto-Injector

Product NDC: 11704-106
11-digit product format: 117040106
Labeler code: 11704
Product ID: 11704-106_f1736bb6-219c-48dd-969d-f26f6fbad350
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atropine
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Meridian Medical Technologies LLC
Application: NDA017106
Marketing category: NDA
Marketing start: 2003-06-19
Substance: ATROPINE
Active strength: 2 mg/.7mL
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N017106-001	ATROPEN	ATROPINE	EQ 2MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD, Approved before 1982
N017106-002	ATROPEN	ATROPINE	EQ 1MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19
N017106-003	ATROPEN	ATROPINE	EQ 0.5MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19
N017106-004	ATROPEN	ATROPINE	EQ 0.25MG SULFATE/0.3ML	SOLUTION / INTRAMUSCULAR	RLD	2004-09-17

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N017106-001	ATROPEN	EQ 2MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017106-002	ATROPEN	EQ 1MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017106-003	ATROPEN	EQ 0.5MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017106-004	ATROPEN	EQ 0.25MG SULFATE/0.3ML	SOLUTION / INTRAMUSCULAR	RLD	2004-09-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017106-001	ATROPEN	EQ 2MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017106-002	ATROPEN	EQ 1MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017106-003	ATROPEN	EQ 0.5MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017106-004	ATROPEN	EQ 0.25MG SULFATE/0.3ML	SOLUTION / INTRAMUSCULAR	RLD	2004-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017106-001	ATROPEN	EQ 2MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017106-002	ATROPEN	EQ 1MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017106-003	ATROPEN	EQ 0.5MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017106-004	ATROPEN	EQ 0.25MG SULFATE/0.3ML	SOLUTION / INTRAMUSCULAR	RLD	2004-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017106-001	ATROPEN	EQ 2MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017106-002	ATROPEN	EQ 1MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017106-003	ATROPEN	EQ 0.5MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017106-004	ATROPEN	EQ 0.25MG SULFATE/0.3ML	SOLUTION / INTRAMUSCULAR	RLD	2004-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017106-001	ATROPEN	EQ 2MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017106-002	ATROPEN	EQ 1MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017106-003	ATROPEN	EQ 0.5MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017106-004	ATROPEN	EQ 0.25MG SULFATE/0.3ML	SOLUTION / INTRAMUSCULAR	RLD	2004-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017106-001	ATROPEN	EQ 2MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017106-002	ATROPEN	EQ 1MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017106-003	ATROPEN	EQ 0.5MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017106-004	ATROPEN	EQ 0.25MG SULFATE/0.3ML	SOLUTION / INTRAMUSCULAR	RLD	2004-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017106-001	ATROPEN	EQ 2MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017106-002	ATROPEN	EQ 1MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017106-003	ATROPEN	EQ 0.5MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017106-004	ATROPEN	EQ 0.25MG SULFATE/0.3ML	SOLUTION / INTRAMUSCULAR	RLD	2004-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017106-001	ATROPEN	EQ 2MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017106-002	ATROPEN	EQ 1MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017106-003	ATROPEN	EQ 0.5MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017106-004	ATROPEN	EQ 0.25MG SULFATE/0.3ML	SOLUTION / INTRAMUSCULAR	RLD	2004-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017106-001	ATROPEN	EQ 2MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017106-002	ATROPEN	EQ 1MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017106-003	ATROPEN	EQ 0.5MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017106-004	ATROPEN	EQ 0.25MG SULFATE/0.3ML	SOLUTION / INTRAMUSCULAR	RLD	2004-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017106-001	ATROPEN	EQ 2MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017106-002	ATROPEN	EQ 1MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017106-003	ATROPEN	EQ 0.5MG SULFATE/0.7ML	SOLUTION / INTRAMUSCULAR	RLD	2003-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017106-004	ATROPEN	EQ 0.25MG SULFATE/0.3ML	SOLUTION / INTRAMUSCULAR	RLD	2004-09-17	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: ATROPEN Auto-Injector
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATROPINE	2 mg/.7mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7C0697DR9I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1190536	Internal RxNorm lookup
1190538	Internal RxNorm lookup
1190540	Internal RxNorm lookup
1190542	Internal RxNorm lookup
1190608	Internal RxNorm lookup
1190611	Internal RxNorm lookup
1190614	Internal RxNorm lookup
1190620	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e2d4307d-da8f-49f5-aac0-02355dd9ffb7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822	Product name	4	20250801
41231c1e-8789-4da7-ac52-77fa90a85bf5	Product name	2	20250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0	Product name	2	20250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407	Product name	4	20240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca	Product name	1	20230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0	Product name	3	20230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5	Product name	4	20210513
4199bf9b-4718-828a-6dd6-ac2fbbd61687	Product name	1	20140508
4edd8af5-cea7-ae42-8023-e91c5335db1d	Product name	1	20140508
d3908afb-7784-440f-c406-88294732d36a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11704-106-01	ATROPEN Auto-Injector	0.7 mL in 1 SYRINGE, PLASTIC	INJECTION	0.7		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11704-106-01	ML - Milliliter	11704-106	47d8a3d1-ec6b-4306-a7c6-562b5de45a58	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Atropine sulfate	ACTIVE INGREDIENT	03J5ZE7KA5	ATROPEN AUTO-INJECTOR (ATROPINE SULFATE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.]	1
Atropine	ACTIVE MOIETY	7C0697DR9I	ATROPEN AUTO-INJECTOR (ATROPINE SULFATE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.]	1
Citric Acid	INACTIVE INGREDIENT	2968PHW8QP	ATROPEN AUTO-INJECTOR (ATROPINE SULFATE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ATROPEN AUTO-INJECTOR (ATROPINE SULFATE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.]	1
Phenol Crystalline	INACTIVE INGREDIENT		ATROPEN AUTO-INJECTOR (ATROPINE SULFATE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.]	1
Sodium Citrate	INACTIVE INGREDIENT	1Q73Q2JULR	ATROPEN AUTO-INJECTOR (ATROPINE SULFATE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11704-106	ATROPEN AUTO-INJECTOR (ATROPINE) INJECTION [MERIDIAN MEDICAL TECHNOLOGIES LLC]	12	Current NDC, Legacy NDC, 1 package rows	20220921_e2d4307d-da8f-49f5-aac0-02355dd9ffb7.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATROPEN Auto-Injector	ATROPINE	Meridian Medical Technologies LLC	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	2022-09-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017106 application number: NDA017106 ndc (product): 11704-106

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7C0697DR9I	ATROPINE	51-55-8	ATROPINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1190608	AtroPen 0.25 MG in 0.3 ML Auto-Injector	PSN	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190611	AtroPen 0.5 MG in 0.7 ML Auto-Injector	PSN	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190614	AtroPen 1 MG in 0.7 ML Auto-Injector	PSN	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190620	AtroPen 2 MG in 0.7 ML Auto-Injector	PSN	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190536	atropine sulfate 0.25 MG in 0.3 ML Auto-Injector	PSN	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190538	atropine sulfate 0.5 MG in 0.7 ML Auto-Injector	PSN	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190540	atropine sulfate 1 MG in 0.7 ML Auto-Injector	PSN	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190542	atropine sulfate 2 MG in 0.7 ML Auto-Injector	PSN	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190608	0.3 ML atropine sulfate 0.833 MG/ML Auto-Injector [Atropen]	SBD	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190611	0.7 ML atropine sulfate 0.714 MG/ML Auto-Injector [Atropen]	SBD	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190614	0.7 ML atropine sulfate 1.43 MG/ML Auto-Injector [Atropen]	SBD	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190620	0.7 ML atropine sulfate 2.86 MG/ML Auto-Injector [Atropen]	SBD	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190536	0.3 ML atropine sulfate 0.833 MG/ML Auto-Injector	SCD	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190538	0.7 ML atropine sulfate 0.714 MG/ML Auto-Injector	SCD	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190540	0.7 ML atropine sulfate 1.43 MG/ML Auto-Injector	SCD	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190542	0.7 ML atropine sulfate 2.86 MG/ML Auto-Injector	SCD	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190608	0.3 ML Atropen 0.833 MG/ML Auto-Injector	SY	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190611	0.7 ML Atropen 0.714 MG/ML Auto-Injector	SY	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190614	0.7 ML Atropen 1.43 MG/ML Auto-Injector	SY	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190620	0.7 ML Atropen 2.86 MG/ML Auto-Injector	SY	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190608	AtroPen 0.25 MG (atropine base 0.21 MG) per 0.3 ML Auto-Injector	SY	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190611	AtroPen 0.5 MG (atropine base 0.42 MG) per 0.7 ML Auto-Injector	SY	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190614	AtroPen 1 MG (atropine base 0.84 MG) per 0.7 ML Auto-Injector	SY	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190620	AtroPen 2 MG (atropine base 1.67 MG) per 0.7 ML Auto-Injector	SY	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190536	atropine sulfate 0.25 MG (atropine 0.21 MG) per 0.3 ML Auto-Injector	SY	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190538	atropine sulfate 0.5 MG (atropine 0.42 MG) per 0.7 ML Auto-Injector	SY	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190540	atropine sulfate 1 MG (atropine 0.84 MG) per 0.7 ML Auto-Injector	SY	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12
1190542	atropine sulfate 2 MG (atropine base 1.67 MG) per 0.7 ML Auto-Injector	SY	e2d4307d-da8f-49f5-aac0-02355dd9ffb7	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
11704-106-01	11704010601	.7 mL in 1 SYRINGE, PLASTIC (11704-106-01)	2003-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATROPEN Auto-Injector	Meridian Medical Technologies LLC	2022-09-15	HUMAN PRESCRIPTION DRUG LABEL	12