Amoxicillin

Product NDC: 65862-070
11-digit product format: 658620070
Labeler code: 65862
Product ID: 65862-070_3e3ca279-1838-4348-a01c-df10a8bcb8b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA065334
Marketing category: ANDA
Marketing start: 2006-12-28
Substance: AMOXICILLIN
Active strength: 200 mg/5mL
Pharmacologic classes: Penicillin-class Antibacterial [EPC], Penicillins [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 42.

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
A065334-001	AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2006-12-28
A065334-002	AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB		2006-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065334-001	AB
A065334-002	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 · 84 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	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065334-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065334-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-12-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A065334-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065334-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065334-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065334-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065334-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065334-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065334-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065334-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065334-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065334-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065334-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065334-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065334-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065334-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065334-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065334-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065334-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065334-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065334-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065334-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065334-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065334-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065334-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065334-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065334-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065334-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065334-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065334-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065334-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065334-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065334-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065334-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065334-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065334-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065334-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065334-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065334-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065334-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065334-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065334-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	200 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308189	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
3cacd754-73f4-496e-a529-9ca39fa6692d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
502415e5-4ac7-4266-a01a-ef44aa3c028d	Product name	7	20250623
d0f377c9-74d8-e2e3-e06e-4d37534f5c0f	Product name	3	20250620
2ebbc361-d28f-48a9-a286-c1ae09cdaf5c	Product name	3	20230314
2bb254ff-3d7f-4bdb-abf9-476506008c55	Product name	1	20230117
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
cf3f1c02-1f32-2322-3314-b70ebbf5610e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-070-01	Amoxicillin	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	15
65862-070-50	Amoxicillin	50 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	50	15
65862-070-75	Amoxicillin	75 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	75	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-070-01	ML - Milliliter	65862-070	4a24e774-8a98-4954-ae04-99212b939d49	1	2012-07-24
65862-070-50	ML - Milliliter	65862-070	4ce48926-2b4e-4d8e-aab9-aefd015f244f	1	2012-07-24
65862-070-75	ML - Milliliter	65862-070	c190b0ae-ec45-48ab-b17d-cbcf55631cee	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	6
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	6
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	6
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	6
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	6
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	6
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	6
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]	2
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]	2
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN POWDER, FOR SUSPENSION [AIDAREX PHARMACEUTICALS LLC]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN POWDER, FOR SUSPENSION [DIRECT RX]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-070	AMOXICILLIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]	15	Current NDC, Legacy NDC, 3 package rows	20240612_3cacd754-73f4-496e-a529-9ca39fa6692d.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	573fcf4a-2b87-45d9-ac73-e1dec4fbc28b	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	2732a8c7-9e4b-43c9-9712-df4b237ab69c	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
AMOXICILLIN	AMOXICILLIN	DirectRx	cedde8f5-aadd-53de-e053-2995a90aab16	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	Rising Pharma Holdings, Inc.	554239db-69fe-405a-910a-d9f9e3f8b6ed	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	97a657a3-8238-f5f1-e053-2a95a90a7a7a	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	Aurobindo Pharma Limited	3cacd754-73f4-496e-a529-9ca39fa6692d	2024-06-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334 ndc (product): 65862-070
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	d5ecb620-5267-4dcf-be81-64c7766516f5	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	3d8a700b-b23b-459a-a19a-213dd39b6a3a	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	1dc5cc5a-59ba-4bc9-b581-cb7b70ce2652	2024-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
AMOXICILLIN	AMOXICILLIN	DIRECT RX	0173e9de-a995-4386-bb65-8fc2bbf347f9	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	Proficient Rx LP	fcdaba34-373f-4d4e-8203-76f02e3bb00a	2024-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	Proficient Rx LP	d5eba477-e255-4d97-9e16-30543c298680	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334
Amoxicillin	AMOXICILLIN	Proficient Rx LP	e40f3e20-facf-46f4-89c7-3593bc27d0fc	2021-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065334 application number: ANDA065334

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313850	amoxicillin 200 MG in 5 mL Oral Suspension	PSN	3cacd754-73f4-496e-a529-9ca39fa6692d	15
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	3cacd754-73f4-496e-a529-9ca39fa6692d	15
313850	amoxicillin 40 MG/ML Oral Suspension	SCD	3cacd754-73f4-496e-a529-9ca39fa6692d	15
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	3cacd754-73f4-496e-a529-9ca39fa6692d	15
313850	amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension	SY	3cacd754-73f4-496e-a529-9ca39fa6692d	15
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	3cacd754-73f4-496e-a529-9ca39fa6692d	15
313850	amoxicillin 200 MG per 5 ML Oral Suspension	SY	3cacd754-73f4-496e-a529-9ca39fa6692d	15
313850	amoxicillin 200 MG in 5 mL Oral Suspension	PSN	573fcf4a-2b87-45d9-ac73-e1dec4fbc28b	4
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	573fcf4a-2b87-45d9-ac73-e1dec4fbc28b	4
313850	amoxicillin 40 MG/ML Oral Suspension	SCD	573fcf4a-2b87-45d9-ac73-e1dec4fbc28b	4
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	573fcf4a-2b87-45d9-ac73-e1dec4fbc28b	4
313850	amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension	SY	573fcf4a-2b87-45d9-ac73-e1dec4fbc28b	4
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	573fcf4a-2b87-45d9-ac73-e1dec4fbc28b	4
313850	amoxicillin 200 MG per 5 ML Oral Suspension	SY	573fcf4a-2b87-45d9-ac73-e1dec4fbc28b	4
313850	amoxicillin 200 MG in 5 mL Oral Suspension	PSN	a91d9ff1-57dc-4569-9d0d-3d1b6ded9773	2
313850	amoxicillin 200 MG in 5 mL Oral Suspension	PSN	4d15e38c-2025-4570-839f-dfd4febd6ce3	2
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	4d15e38c-2025-4570-839f-dfd4febd6ce3	2
313850	amoxicillin 40 MG/ML Oral Suspension	SCD	4d15e38c-2025-4570-839f-dfd4febd6ce3	2
313850	amoxicillin 40 MG/ML Oral Suspension	SCD	a91d9ff1-57dc-4569-9d0d-3d1b6ded9773	2
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	4d15e38c-2025-4570-839f-dfd4febd6ce3	2
313850	amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension	SY	4d15e38c-2025-4570-839f-dfd4febd6ce3	2
313850	amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension	SY	a91d9ff1-57dc-4569-9d0d-3d1b6ded9773	2
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	4d15e38c-2025-4570-839f-dfd4febd6ce3	2
313850	amoxicillin 200 MG per 5 ML Oral Suspension	SY	4d15e38c-2025-4570-839f-dfd4febd6ce3	2
313850	amoxicillin 200 MG per 5 ML Oral Suspension	SY	a91d9ff1-57dc-4569-9d0d-3d1b6ded9773	2
313850	amoxicillin 200 MG in 5 mL Oral Suspension	PSN	d5eba477-e255-4d97-9e16-30543c298680	1
313850	amoxicillin 40 MG/ML Oral Suspension	SCD	d5eba477-e255-4d97-9e16-30543c298680	1
313850	amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension	SY	d5eba477-e255-4d97-9e16-30543c298680	1
313850	amoxicillin 200 MG per 5 ML Oral Suspension	SY	d5eba477-e255-4d97-9e16-30543c298680	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-070-01	65862007001	100 mL in 1 BOTTLE (65862-070-01)	100 ml	2006-12-28	0000-00-00	No	No	Current
65862-070-50	65862007050	50 mL in 1 BOTTLE (65862-070-50)	50 ml	2006-12-28	0000-00-00	No	No	Current
65862-070-75	65862007075	75 mL in 1 BOTTLE (65862-070-75)	75 ml	2006-12-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin	Preferred Pharmaceuticals Inc.	2026-03-04	HUMAN PRESCRIPTION DRUG LABEL	4
Amoxicillin	Aurobindo Pharma Limited	2024-06-13	Human Prescription Drug Label	15
Amoxicillin	A-S Medication Solutions	2024-04-29	Human Prescription Drug Label	7
Amoxicillin	Proficient Rx LP	2023-03-01	HUMAN PRESCRIPTION DRUG LABEL	1
AMOXICILLIN	DIRECT RX	2015-11-06	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin	Aidarex Pharmaceuticals LLC	2013-11-21	HUMAN PRESCRIPTION DRUG LABEL	2