Amoxicillin

Product NDC: 0143-9887
11-digit product format: 001439887
Labeler code: 0143
Product ID: 0143-9887_606474e1-adba-4ffa-83d5-6565fc12c892
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA065325
Marketing category: ANDA
Marketing start: 2006-06-19
Substance: AMOXICILLIN
Active strength: 400 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 1.

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
A065325-001	AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB		2006-06-19
A065325-002	AMOXICILLIN	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB		2006-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065325-001	AB
A065325-002	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 · 82 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	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065325-001	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065325-002	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2006-06-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A065325-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065325-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065325-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065325-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065325-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065325-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065325-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065325-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065325-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065325-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065325-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065325-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065325-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065325-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065325-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065325-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065325-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065325-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065325-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065325-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065325-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065325-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065325-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065325-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065325-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065325-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065325-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065325-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065325-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065325-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065325-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065325-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065325-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065325-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065325-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065325-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065325-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065325-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065325-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065325-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

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 · 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
d46f1091-33dc-4f8f-9c34-75dcfedb4b4c	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
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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
0143-9887-01	Amoxicillin	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	24
0143-9887-50	Amoxicillin	50 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	50	24
0143-9887-75	Amoxicillin	75 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	75	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-9887-01	ML - Milliliter	0143-9887	17d82ecd-07bc-46cb-bc3a-b6938b6beab5	1	2012-07-24
0143-9887-50	ML - Milliliter	0143-9887	6933d03b-b3b7-4edd-850c-93a61c685cbb	1	2012-07-24
0143-9887-75	ML - Milliliter	0143-9887	0afcfed4-8142-4198-82fa-4b1f73141e0d	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 [WEST-WARD PHARMACEUTICAL CORP]	16
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	16
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	16
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	16
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	16
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	16
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	AMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	16
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN POWDER, FOR SUSPENSION [WEST-WARD PHARMACEUTICAL CORP]	16
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
TRISODIUM CITRATE DIHYDRATE	INACTIVE INGREDIENT	B22547B95K	AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-9887	AMOXICILLIN POWDER, FOR SUSPENSION [HIKMA PHARMACEUTICALS USA INC.]	24	Current NDC, Legacy NDC, 3 package rows	20240704_d46f1091-33dc-4f8f-9c34-75dcfedb4b4c.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	afef7c71-2d19-41ed-9213-b32ccc1bf1d3	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	c0e333d9-164d-4196-b5f5-929993d1c3c2	2026-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	Preferred Pharmaceuticals Inc.	992d7829-34d1-4c88-8a5c-1a92d001d194	2025-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxil	AMOXICILLIN ORAL SUSP	DirectRx	ec7dd735-dc92-3d29-e053-2a95a90af549	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	59a546ed-84b7-a54a-e053-2991aa0a3a0d	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	8398f2c9-37ca-9b59-e053-2991aa0a2c11	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	Hikma Pharmaceuticals USA Inc.	d46f1091-33dc-4f8f-9c34-75dcfedb4b4c	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325 ndc (product): 0143-9887
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	cef5b1ae-8454-4e7a-8830-dd5d601c1d21	2023-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	156ef8e9-b6e4-4512-865f-7139c90c8f9b	2023-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	A-S Medication Solutions	77265bcd-c05d-443a-84c4-6e5ac75ee42c	2023-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325
Amoxicillin	AMOXICILLIN	Proficient Rx LP	756545f1-77af-49a0-a697-4cced31711d4	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065325 application number: ANDA065325

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	d46f1091-33dc-4f8f-9c34-75dcfedb4b4c	24
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	d46f1091-33dc-4f8f-9c34-75dcfedb4b4c	24
313850	amoxicillin 40 MG/ML Oral Suspension	SCD	d46f1091-33dc-4f8f-9c34-75dcfedb4b4c	24
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	d46f1091-33dc-4f8f-9c34-75dcfedb4b4c	24
313850	amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension	SY	d46f1091-33dc-4f8f-9c34-75dcfedb4b4c	24
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	d46f1091-33dc-4f8f-9c34-75dcfedb4b4c	24
313850	amoxicillin 200 MG per 5 ML Oral Suspension	SY	d46f1091-33dc-4f8f-9c34-75dcfedb4b4c	24
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	cef5b1ae-8454-4e7a-8830-dd5d601c1d21	17
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	cef5b1ae-8454-4e7a-8830-dd5d601c1d21	17
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	cef5b1ae-8454-4e7a-8830-dd5d601c1d21	17
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	156ef8e9-b6e4-4512-865f-7139c90c8f9b	16
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	156ef8e9-b6e4-4512-865f-7139c90c8f9b	16
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	156ef8e9-b6e4-4512-865f-7139c90c8f9b	16
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	77265bcd-c05d-443a-84c4-6e5ac75ee42c	9
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	77265bcd-c05d-443a-84c4-6e5ac75ee42c	9
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	77265bcd-c05d-443a-84c4-6e5ac75ee42c	9
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	59a546ed-84b7-a54a-e053-2991aa0a3a0d	5
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	59a546ed-84b7-a54a-e053-2991aa0a3a0d	5
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	59a546ed-84b7-a54a-e053-2991aa0a3a0d	5
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	4a57711c-befe-488c-9cbc-d92e89c425ed	4
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	4a57711c-befe-488c-9cbc-d92e89c425ed	4
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	4a57711c-befe-488c-9cbc-d92e89c425ed	4
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	8398f2c9-37ca-9b59-e053-2991aa0a2c11	3
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	c0e333d9-164d-4196-b5f5-929993d1c3c2	3
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	8398f2c9-37ca-9b59-e053-2991aa0a2c11	3
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	c0e333d9-164d-4196-b5f5-929993d1c3c2	3
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	c0e333d9-164d-4196-b5f5-929993d1c3c2	3
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	8398f2c9-37ca-9b59-e053-2991aa0a2c11	3
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	756545f1-77af-49a0-a697-4cced31711d4	2
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	d72d2646-1d2f-4f0e-a56d-7891e13891b5	2
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	756545f1-77af-49a0-a697-4cced31711d4	2
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	d72d2646-1d2f-4f0e-a56d-7891e13891b5	2
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	756545f1-77af-49a0-a697-4cced31711d4	2
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	d72d2646-1d2f-4f0e-a56d-7891e13891b5	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-9887-01	00143988701	100 mL in 1 BOTTLE (0143-9887-01)	100 ml	2006-06-19	0000-00-00	No	No	Current
0143-9887-50	00143988750	50 mL in 1 BOTTLE (0143-9887-50)	50 ml	2006-06-19	0000-00-00	No	No	Current
0143-9887-75	00143988775	75 mL in 1 BOTTLE (0143-9887-75)	75 ml	2006-06-19	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	3
Amoxicillin Oral Susp	DirectRx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	3
Amoxicillin	NuCare Pharmaceuticals,Inc.	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL	5
Amoxicillin	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	3
Amoxicillin	Preferred Pharmaceuticals, Inc.	2024-02-09	HUMAN PRESCRIPTION DRUG LABEL	13
Amoxicillin	Hikma Pharmaceuticals USA Inc.	2024-02-01	HUMAN PRESCRIPTION DRUG LABEL	24
Amoxicillin	A-S Medication Solutions	2023-12-09	HUMAN PRESCRIPTION DRUG LABEL	17
Amoxicillin	RPK Pharmaceuticals, Inc.	2023-10-23	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin	A-S Medication Solutions	2023-09-10	HUMAN PRESCRIPTION DRUG LABEL	16
Amoxicillin	A-S Medication Solutions	2023-02-21	HUMAN PRESCRIPTION DRUG LABEL	9
Amoxicillin	Proficient Rx LP	2022-06-01	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin	Lake Erie Medical DBA Quality Care Products LLC \| Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	2021-10-19	HUMAN PRESCRIPTION DRUG LABEL	45
Amoxicillin	NuCare Pharmaceuticals,Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	2
Amoxicillin	Unit Dose Services	2017-03-07	HUMAN PRESCRIPTION DRUG LABEL	4