DuoDote

Product NDC: 11704-620
11-digit product format: 117040620
Labeler code: 11704
Product ID: 11704-620_b301a110-424c-4a7d-9560-8fbfbbd1a557
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atropine and pralidoxime chloride
Dosage form: KIT
Route: INTRAMUSCULAR
Labeler: Meridian Medical Technologies� LLC
Application: NDA021983
Marketing category: NDA
Marketing start: 2006-09-28
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021983-001	DUODOTE	ATROPINE; PRALIDOXIME CHLORIDE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR		RLD, RS	2006-09-28

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021983-001	DUODOTE	2.1MG/0.7ML;600MG/2ML	INJECTABLE / INTRAMUSCULAR	RLD, RS	2006-09-28	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: DuoDote
Listing expiration: 2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
727415	Internal RxNorm lookup
809819	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
241f42a0-1a33-40e8-8221-201767d999e5	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
0395ee9f-b6e0-2e52-6ab9-39f69ba534d5	Product name	1	20140508
4199bf9b-4718-828a-6dd6-ac2fbbd61687	Product name	1	20140508
4edd8af5-cea7-ae42-8023-e91c5335db1d	Product name	1	20140508
9869efd7-d6dd-0665-5b67-53adbe6ef15e	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
11704-620-01	DuoDote	1 in 1 CARTON	KIT	1		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11704-620-01	ML - Milliliter	11704-620	1903bac1-36f4-4344-b28f-626f25c34b8b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Atropine	ACTIVE INGREDIENT	7C0697DR9I	DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE) KIT [MERIDIAN MEDICAL TECHNOLOGIES , INC.]	3
Pralidoxime Chloride	ACTIVE INGREDIENT	38X7XS076H	DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE) KIT [MERIDIAN MEDICAL TECHNOLOGIES , INC.]	3
Atropine	ACTIVE MOIETY	7C0697DR9I	DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE) KIT [MERIDIAN MEDICAL TECHNOLOGIES , INC.]	3
Pralidoxime	ACTIVE MOIETY	P7MU9UTP52	DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE) KIT [MERIDIAN MEDICAL TECHNOLOGIES , INC.]	3
Benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE) KIT [MERIDIAN MEDICAL TECHNOLOGIES , INC.]	3
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE) KIT [MERIDIAN MEDICAL TECHNOLOGIES , INC.]	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE) KIT [MERIDIAN MEDICAL TECHNOLOGIES , INC.]	3
glycine	INACTIVE INGREDIENT	TE7660XO1C	DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE) KIT [MERIDIAN MEDICAL TECHNOLOGIES , INC.]	3
phenol	INACTIVE INGREDIENT	339NCG44TV	DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE) KIT [MERIDIAN MEDICAL TECHNOLOGIES , INC.]	3
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE) KIT [MERIDIAN MEDICAL TECHNOLOGIES , INC.]	3
water	INACTIVE INGREDIENT	059QF0KO0R	DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE) KIT [MERIDIAN MEDICAL TECHNOLOGIES , INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11704-620	DUODOTE (ATROPINE AND PRALIDOXIME CHLORIDE) KIT [MERIDIAN MEDICAL TECHNOLOGIES&REG; LLC]	17	Current NDC, Legacy NDC, 1 package rows	20220630_241f42a0-1a33-40e8-8221-201767d999e5.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
DuoDote	ATROPINE AND PRALIDOXIME CHLORIDE	Meridian Medical Technologies LLC	241f42a0-1a33-40e8-8221-201767d999e5	2022-04-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021983 application number: NDA021983 ndc (product): 11704-620

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
727415	atropine 2.1 MG / pralidoxime Cl 600 MG Auto-Injector	PSN	241f42a0-1a33-40e8-8221-201767d999e5	17
809819	DuoDote (atropine 2.1 MG / pralidoxime Cl 600 MG) Auto-Injector	PSN	241f42a0-1a33-40e8-8221-201767d999e5	17
809819	2.7 ML atropine 0.778 MG/ML / pralidoxime chloride 222 MG/ML Auto-Injector [Duodote]	SBD	241f42a0-1a33-40e8-8221-201767d999e5	17
727415	2.7 ML atropine 0.778 MG/ML / pralidoxime chloride 222 MG/ML Auto-Injector	SCD	241f42a0-1a33-40e8-8221-201767d999e5	17
727415	atropine 2.1 MG / pralidoxime chloride 600 MG Auto-Injector	SY	241f42a0-1a33-40e8-8221-201767d999e5	17
809819	Duodote (atropine 2.1 MG / pralidoxime chloride 600 MG) Auto-Injector	SY	241f42a0-1a33-40e8-8221-201767d999e5	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11704-620-01	11704062001	1 KIT in 1 CARTON (11704-620-01) * 1 POUCH in 1 CARTON / 1 SYRINGE, PLASTIC in 1 POUCH / .7 mL in 1 SYRINGE, PLASTIC * 1 POUCH in 1 CARTON / 1 SYRINGE, PLASTIC in 1 POUCH / 2 mL in 1 SYRINGE, PLASTIC	1 kit	2006-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DuoDote	Meridian Medical Technologies® LLC \| Meridian Medical Technologies LLC	2022-04-04	HUMAN PRESCRIPTION DRUG LABEL	17