Atracurium Besylate

Product NDC: 55150-216
11-digit product format: 551500216
Labeler code: 55150
Product ID: 55150-216_379b43a8-f4ba-4a29-a478-23dbb33fbefa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atracurium Besylate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: AuroMedics Pharma LLC
Application: ANDA206010
Marketing category: ANDA
Marketing start: 2015-04-08
Substance: ATRACURIUM BESYLATE
Active strength: 50 mg/5mL
Pharmacologic classes: Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	ATRACURIUM BESYLATE	10MG/ML	INJECTABLE / INJECTION			2015-04-08

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION		2015-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION		2015-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION		2015-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION		2015-04-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206010-001	ATRACURIUM BESYLATE PRESERVATIVE FREE	10MG/ML	INJECTABLE / INJECTION	AP	2015-04-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206010-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206010-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206010-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206010-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206010-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206010-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206010-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206010-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206010-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206010-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206010-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206010-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206010-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206010-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206010-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206010-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206010-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206010-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206010-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206010-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206010-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206010-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206010-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206010-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206010-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206010-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206010-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206010-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206010-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206010-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206010-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206010-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206010-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206010-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206010-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206010-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206010-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATRACURIUM BESYLATE	50 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
40AX66P76P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1718913	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
71d4bc78-57df-474b-8b19-811a959f1fce	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ee531c6f-519c-e9d0-f89e-d306203b9c49	Product name	4	20170804

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55150-216-05	Atracurium Besylate	10 in 1 CARTON	INJECTION, SOLUTION	10		5
55150-216-05	Atracurium Besylate	5 mL in 1 VIAL, SINGLE-USE	INJECTION, SOLUTION	5		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55150-216-05	ML - Milliliter	55150-216	463b0352-70ba-4085-9a0c-d5c96033dae3	1	2015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATRACURIUM BESYLATE	ACTIVE INGREDIENT	40AX66P76P	ATRACURIUM BESYLATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	1
ATRACURIUM	ACTIVE MOIETY	2GQ1IRY63P	ATRACURIUM BESYLATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	1
BENZENESULFONIC ACID	INACTIVE INGREDIENT	685928Z18A	ATRACURIUM BESYLATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ATRACURIUM BESYLATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-216	ATRACURIUM BESYLATE INJECTION, SOLUTION [AUROMEDICS PHARMA LLC]	5	Current NDC, Legacy NDC, 2 package rows	20220531_71d4bc78-57df-474b-8b19-811a959f1fce.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
Atracurium Besylate	ATRACURIUM BESYLATE	AuroMedics Pharma LLC	71d4bc78-57df-474b-8b19-811a959f1fce	2022-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206010 application number: ANDA206010 ndc (product): 55150-216

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
40AX66P76P	ATRACURIUM BESYLATE	64228-81-5	ATRACURIUM BESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1718913	atracurium besylate 50 MG in 5 ML Injection	PSN	71d4bc78-57df-474b-8b19-811a959f1fce	5
1718913	5 ML atracurium besylate 10 MG/ML Injection	SCD	71d4bc78-57df-474b-8b19-811a959f1fce	5
1718913	atracurium besylate 50 MG per 5 ML Injection	SY	71d4bc78-57df-474b-8b19-811a959f1fce	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55150-216-05	55150021605	10 VIAL, SINGLE-USE in 1 CARTON (55150-216-05) / 5 mL in 1 VIAL, SINGLE-USE	2015-04-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atracurium Besylate - AuroMedics Pharma LLC \| Eugia Pharma Specialities Limited	AuroMedics Pharma LLC \| Eugia Pharma Specialities Limited	2022-05-30	Human Prescription Drug Label	5