Amoxicillin

Product NDC: 0781-6156
11-digit product format: 007816156
Labeler code: 0781
Product ID: 0781-6156_6aa02079-d11c-4d2f-acaf-9548dd9a7ed6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA065378
Marketing category: ANDA
Marketing start: 2007-03-26
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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A065378-001	AMOXICILLIN	200MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065378-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-03-26	`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	A065378-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065378-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065378-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065378-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065378-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065378-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065378-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065378-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065378-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065378-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065378-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065378-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065378-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065378-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065378-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065378-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065378-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065378-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065378-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065378-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065378-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065378-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065378-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065378-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065378-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065378-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065378-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065378-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065378-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065378-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065378-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065378-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065378-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065378-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065378-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065378-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065378-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065378-002	AB	1	`74a2ff9319b5…`
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…`

Additional Listing Data#

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

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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
239191	Internal RxNorm lookup
308182	Internal RxNorm lookup
308189	Internal RxNorm lookup
308191	Internal RxNorm lookup
308192	Internal RxNorm lookup
308194	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
13bd4214-9b7f-425b-af5f-fc1ddc678230	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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
f33561b9-47cb-411c-a228-16c62e346cd4	Product name	1	20200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
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
0781-6156-46	Amoxicillin	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100	25
0781-6156-52	Amoxicillin	50 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	50	25
0781-6156-57	Amoxicillin	75 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	75	25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-6156-46	ML - Milliliter	0781-6156	b514881e-441f-4e92-b13c-88a9fa5ae6b3	1	2012-07-24
0781-6156-52	ML - Milliliter	0781-6156	3ed3b5a3-498b-4062-b525-e3545f65666f	1	2012-07-24
0781-6156-57	ML - Milliliter	0781-6156	13467e5b-a8a1-49a2-a2ba-b0108d4801eb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
ANHYDROUS TRISODIUM CITRATE	INACTIVE INGREDIENT	RS7A450LGA	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
SHELLAC	INACTIVE INGREDIENT	46N107B71O	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
WATER	INACTIVE INGREDIENT	059QF0KO0R	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	13
AMOXICILLIN	ACTIVE INGREDIENT	804826J2HU	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
AMOXICILLIN ANHYDROUS	ACTIVE MOIETY	9EM05410Q9	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
ANHYDROUS TRISODIUM CITRATE	INACTIVE INGREDIENT	RS7A450LGA	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
SUCROSE	INACTIVE INGREDIENT	C151H8M554	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-6156	AMOXICILLIN CAPSULE AMOXICILLIN TABLET, FILM COATED AMOXICILLIN POWDER, FOR SUSPENSION [SANDOZ INC]	23	Current NDC, Legacy NDC, 3 package rows	20250116_13bd4214-9b7f-425b-af5f-fc1ddc678230.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 · 6 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
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	81fe142e-a163-4632-93fb-7cd8d80c50bd	2025-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065378 application number: ANDA065378
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 ndc (product): 0781-6156
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313797	amoxicillin 125 MG in 5 mL Oral Suspension	PSN	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
313850	amoxicillin 200 MG in 5 mL Oral Suspension	PSN	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
239191	amoxicillin 250 MG in 5 mL Oral Suspension	PSN	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308182	amoxicillin 250 MG Oral Capsule	PSN	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308191	amoxicillin 500 MG Oral Capsule	PSN	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308192	amoxicillin 500 MG Oral Tablet	PSN	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308194	amoxicillin 875 MG Oral Tablet	PSN	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
313797	amoxicillin 25 MG/ML Oral Suspension	SCD	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308182	amoxicillin 250 MG Oral Capsule	SCD	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
313850	amoxicillin 40 MG/ML Oral Suspension	SCD	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
239191	amoxicillin 50 MG/ML Oral Suspension	SCD	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308191	amoxicillin 500 MG Oral Capsule	SCD	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308192	amoxicillin 500 MG Oral Tablet	SCD	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308194	amoxicillin 875 MG Oral Tablet	SCD	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
313797	amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral Suspension	SY	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
313850	amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension	SY	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
239191	amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral Suspension	SY	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
308194	amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet	SY	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
313797	amoxicillin 125 MG per 5 ML Oral Suspension	SY	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
313850	amoxicillin 200 MG per 5 ML Oral Suspension	SY	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
239191	amoxicillin 250 MG per 5 ML Oral Suspension	SY	13bd4214-9b7f-425b-af5f-fc1ddc678230	25
313797	amoxicillin 125 MG in 5 mL Oral Suspension	PSN	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
313850	amoxicillin 200 MG in 5 mL Oral Suspension	PSN	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
239191	amoxicillin 250 MG in 5 mL Oral Suspension	PSN	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
308182	amoxicillin 250 MG Oral Capsule	PSN	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
308191	amoxicillin 500 MG Oral Capsule	PSN	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
308194	amoxicillin 875 MG Oral Tablet	PSN	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
313797	amoxicillin 25 MG/ML Oral Suspension	SCD	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
308182	amoxicillin 250 MG Oral Capsule	SCD	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
313850	amoxicillin 40 MG/ML Oral Suspension	SCD	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
239191	amoxicillin 50 MG/ML Oral Suspension	SCD	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
308191	amoxicillin 500 MG Oral Capsule	SCD	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
308194	amoxicillin 875 MG Oral Tablet	SCD	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
313797	amoxicillin (as amoxicillin trihydrate) 125 MG per 5 ML Oral Suspension	SY	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
313850	amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension	SY	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
308182	amoxicillin (as amoxicillin trihydrate) 250 MG Oral Capsule	SY	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
239191	amoxicillin (as amoxicillin trihydrate) 250 MG per 5 ML Oral Suspension	SY	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
308194	amoxicillin (as amoxicillin trihydrate) 875 MG Oral Tablet	SY	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
313797	amoxicillin 125 MG per 5 ML Oral Suspension	SY	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
313850	amoxicillin 200 MG per 5 ML Oral Suspension	SY	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
239191	amoxicillin 250 MG per 5 ML Oral Suspension	SY	daa89601-3e7c-4d9e-9bed-fd6abf20348e	6
313850	amoxicillin 200 MG in 5 mL Oral Suspension	PSN	d6456a2c-1988-4c96-a6fe-3fa157a2cea8	1
313850	amoxicillin 40 MG/ML Oral Suspension	SCD	d6456a2c-1988-4c96-a6fe-3fa157a2cea8	1
313850	amoxicillin (as amoxicillin trihydrate) 200 MG per 5 ML Oral Suspension	SY	d6456a2c-1988-4c96-a6fe-3fa157a2cea8	1
313850	amoxicillin 200 MG per 5 ML Oral Suspension	SY	d6456a2c-1988-4c96-a6fe-3fa157a2cea8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-6156-46	00781615646	100 mL in 1 BOTTLE (0781-6156-46)	100 ml	2007-03-26	0000-00-00	No	No	Current
0781-6156-52	00781615652	50 mL in 1 BOTTLE (0781-6156-52)	50 ml	2007-03-26	0000-00-00	No	No	Current
0781-6156-57	00781615657	75 mL in 1 BOTTLE (0781-6156-57)	75 ml	2007-03-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amoxicillin	HAWAII REPACK, INC.	2026-07-03	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin	Sandoz Inc	2025-05-01	HUMAN PRESCRIPTION DRUG LABEL	25
Amoxicillin	A-S Medication Solutions	2020-10-08	HUMAN PRESCRIPTION DRUG LABEL	1
AMOXICILLIN ORAL SUSP	DIRECTRX	2019-04-02	HUMAN PRESCRIPTION DRUG LABEL	1
Amoxicillin Capsules, Tablets and Powder for Oral Suspension, USP	Physicians Total Care, Inc.	2012-02-08	HUMAN PRESCRIPTION DRUG LABEL	6