Amoxicillin

Product NDC: 62135-815
Requested package NDC: 62135-815-42
11-digit product format: 621350815
Labeler code: 62135
Product ID: 62135-815_4690e611-3a29-35ce-e063-6294a90a5e9e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA065319
Marketing category: ANDA
Marketing start: 2007-06-18
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 43.

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
A065319-002	AMOXICILLIN	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB		2007-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065319-002	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 2 · 43 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	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065319-002	AMOXICILLIN	400MG/5ML	FOR SUSPENSION / ORAL	AB	2007-06-18	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065319-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065319-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065319-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065319-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065319-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065319-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065319-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065319-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065319-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065319-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065319-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065319-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065319-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065319-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065319-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065319-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065319-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065319-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065319-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065319-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065319-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065319-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065319-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065319-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065319-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065319-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065319-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065319-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065319-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065319-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065319-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065319-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065319-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065319-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065319-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065319-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065319-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065319-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065319-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065319-002	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: 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308189	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
1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f	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	Strength	SPL version
62135-815-42	Amoxicillin	100 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	100		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-815	AMOXICILLIN POWDER, FOR SUSPENSION [CHARTWELL RX, LLC]	1	Current NDC, 1 package rows	20240630_1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f.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
Amoxicillin	AMOXICILLIN	Chartwell RX, LLC	1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065319 application number: ANDA065319 ndc (package): 62135-815-42 ndc (product): 62135-815 ndc11 (package): 62135081542

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
308189	amoxicillin 400 MG in 5 mL Oral Suspension	PSN	1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f	2
308189	amoxicillin 80 MG/ML Oral Suspension	SCD	1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f	2
308189	amoxicillin (as amoxicillin trihydrate) 400 MG per 5 ML Oral Suspension	SY	1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-815-42	62135081542	100 mL in 1 BOTTLE (62135-815-42)	100 ml	2024-06-25	No	No	Current