Amoxicillin

Product NDC: 85534-0073
11-digit product format: 855340073
Labeler code: 85534
Product ID: 85534-0073_55af4d00-f2af-456b-e063-6394a90a75e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: HAWAII REPACK, INC.
Application: ANDA065378
Marketing category: ANDA
Marketing start: 2007-03-26
Substance: AMOXICILLIN
Active strength: 400 mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A065378-001	AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2007-03-26
A065378-002	AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB		2007-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A065378-001	AB
A065378-002	AB

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 3 · 86 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
2026-09-14 22:38:34	2026-08	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A065378-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065378-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065378-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065378-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065378-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065378-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065378-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A065378-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065378-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A065378-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065378-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A065378-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065378-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A065378-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065378-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A065378-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065378-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A065378-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065378-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065378-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065378-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A065378-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065378-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A065378-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065378-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065378-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065378-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065378-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065378-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065378-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065378-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065378-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065378-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A065378-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065378-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A065378-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065378-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065378-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065378-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A065378-002	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Amoxicillin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	400 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
804826J2HU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
239191	Internal RxNorm lookup
308189	Internal RxNorm lookup
313797	Internal RxNorm lookup
313850	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
669a243e-249d-4ccb-9693-66de073e53bb	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	HAWAII REPACK, INC.	669a243e-249d-4ccb-9693-66de073e53bb	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065378 application number: ANDA065378 ndc (product): 85534-0073
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	830bb8fb-3743-463a-9317-3f83e3e105ac	2024-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065378 application number: ANDA065378
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	997650f9-7eff-64de-e053-2995a90a617b	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065378 application number: ANDA065378
Amoxicillin	AMOXICILLIN	Sandoz Inc	13bd4214-9b7f-425b-af5f-fc1ddc678230	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065378 application number: ANDA065378
Amoxicillin	AMOXICILLIN	Proficient Rx LP	ead1e453-af08-4a3b-8379-aa182dff514b	2020-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065378 application number: ANDA065378

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
804826J2HU	AMOXICILLIN	61336-70-7	AMOXICILLIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85534-0073-0	85534007300	50 mL in 1 BOTTLE (85534-0073-0)	50 ml	2026-07-03	No	No	Current
85534-0073-1	85534007301	75 mL in 1 BOTTLE (85534-0073-1)	75 ml	2026-07-03	No	No	Current
85534-0073-2	85534007302	100 mL in 1 BOTTLE (85534-0073-2)	100 ml	2026-07-03	No	No	Current