Amikacin Sulfate

Product NDC: 0641-6167
11-digit product format: 006416167
Labeler code: 0641
Product ID: 0641-6167_36fb925f-8beb-4691-9136-500772c736fa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amikacin Sulfate
Dosage form: INJECTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA063315
Marketing category: ANDA
Marketing start: 2015-08-01
Substance: AMIKACIN SULFATE
Active strength: 250 mg/mL
Pharmacologic classes: Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
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
A063315-001	AMIKACIN SULFATE	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP		1994-04-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A063315-001	AP

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063315-001	AMIKACIN SULFATE	EQ 250MG BASE/ML	INJECTABLE / INJECTION	AP	1994-04-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A063315-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A063315-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A063315-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A063315-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A063315-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A063315-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A063315-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A063315-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A063315-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A063315-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A063315-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A063315-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A063315-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A063315-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A063315-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A063315-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A063315-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A063315-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A063315-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A063315-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A063315-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A063315-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A063315-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A063315-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A063315-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A063315-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A063315-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A063315-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A063315-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A063315-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A063315-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A063315-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A063315-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A063315-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A063315-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A063315-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A063315-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A063315-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A063315-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A063315-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMIKACIN SULFATE	250 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N6M33094FD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1723156	Internal RxNorm lookup
1723160	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
0b56f6df-a05d-4520-8bf0-d7cefe20f6ad	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e1d8d349-40e8-4ab6-9f36-aa84681732ed	Product name	3	20250124
7a2acf42-1a2f-4e31-9d74-f6d541e9bb46	Product name	1	20190111
37302fde-6a8c-4412-a7e0-b0fdb78cc567	Product name	1	20151215
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6167-01	Amikacin Sulfate	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2		10
0641-6167-10	Amikacin Sulfate	10 in 1 CARTON	INJECTION	10		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6167-01	ML - Milliliter	0641-6167	08299c4a-851a-4ec8-8eae-65f339796265	1	2016-01-13
0641-6167-10	ML - Milliliter	0641-6167	1020a033-d4d8-4359-ba05-2f1902ea03e8	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMIKACIN SULFATE	ACTIVE INGREDIENT	N6M33094FD	AMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]	3
AMIKACIN	ACTIVE MOIETY	84319SGC3C	AMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]	3
SODIUM CITRATE, UNSPECIFIED FORM	INACTIVE INGREDIENT	1Q73Q2JULR	AMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]	3
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	AMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]	3
SULFURIC ACID	INACTIVE INGREDIENT	O40UQP6WCF	AMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	AMIKACIN SULFATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6167	AMIKACIN SULFATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]	10	Current NDC, Legacy NDC, 2 package rows	20240410_0b56f6df-a05d-4520-8bf0-d7cefe20f6ad.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
Amikacin Sulfate	AMIKACIN SULFATE	Hikma Pharmaceuticals USA Inc.	0b56f6df-a05d-4520-8bf0-d7cefe20f6ad	2024-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 063315 application number: ANDA063315 ndc (product): 0641-6167

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N6M33094FD	AMIKACIN SULFATE	39831-55-5	AMIKACIN SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1723160	amikacin sulfate 1 GM in 4 ML Injection	PSN	0b56f6df-a05d-4520-8bf0-d7cefe20f6ad	10
1723156	amikacin sulfate 500 MG in 2 ML Injection	PSN	0b56f6df-a05d-4520-8bf0-d7cefe20f6ad	10
1723156	2 ML amikacin 250 MG/ML Injection	SCD	0b56f6df-a05d-4520-8bf0-d7cefe20f6ad	10
1723160	4 ML amikacin 250 MG/ML Injection	SCD	0b56f6df-a05d-4520-8bf0-d7cefe20f6ad	10
1723160	amikacin (as amikacin sulfate) 1 GM per 4 ML Injection	SY	0b56f6df-a05d-4520-8bf0-d7cefe20f6ad	10
1723156	amikacin (as amikacin sulfate) 500 MG per 2 ML Injection	SY	0b56f6df-a05d-4520-8bf0-d7cefe20f6ad	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0641-6167-01	00641616701	2 mL in 1 VIAL, SINGLE-DOSE	2 ml					Historical
0641-6167-10	00641616710	10 VIAL, SINGLE-DOSE in 1 CARTON (0641-6167-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0641-6167-01)		2015-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMIKACIN SULFATE INJECTION, USP	Hikma Pharmaceuticals USA Inc.	2024-04-08	HUMAN PRESCRIPTION DRUG LABEL	10