Amoxicillin

Product NDC: 70518-2190
Requested package NDC: 70518-2190-2
11-digit product format: 705182190
Labeler code: 70518
Product ID: 70518-2190_4b429aac-3140-b84d-e063-6394a90a991f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amoxicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA064076
Marketing category: ANDA
Marketing start: 2019-07-09
Substance: AMOXICILLIN
Active strength: 500 mg/1
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 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
A064076-001	AMOXICILLIN	AMOXICILLIN	250MG	CAPSULE / ORAL	AB		1994-09-30
A064076-002	AMOXICILLIN	AMOXICILLIN	500MG	CAPSULE / ORAL	AB		1994-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064076-001	AB
A064076-002	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A064076-001	AMOXICILLIN	250MG	CAPSULE / ORAL	AB		1994-09-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A064076-002	AMOXICILLIN	500MG	CAPSULE / ORAL	AB		1994-09-30	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A064076-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A064076-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	102c62ca-da20-4866-84a8-e3513824af4a	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076 ndc (package): 70518-2190-2 ndc (product): 70518-2190 ndc11 (package): 70518219002
Amoxicillin	AMOXICILLIN	Northwind Health Company, LLC	4ecefd37-9847-1d93-e063-6394a90a19f0	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Coupler LLC	52bd03c6-528a-c443-e063-6394a90aad39	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	be7d8459-b8e6-499a-ab87-99bd17492525	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	QPharma Inc	ddd1307d-3216-0e59-e053-2995a90ad19d	2026-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Coupler LLC	50fff2b8-8bf1-ff46-e063-6394a90a9213	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	82c0c5d1-df2d-4352-bd12-99f955af569e	2026-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	REMEDYREPACK INC.	bb95fd06-f200-4de3-bfae-84d642d8e0f3	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	76ba0f8d-4d1c-a5ff-e053-2a91aa0a7555	2024-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	NuCare Pharmaceuticals,Inc.	6e9bf369-2f96-c7ae-e053-2a91aa0a715f	2024-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	7b182161-128e-430c-98b2-592c242ba711	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	260a3a79-9dd6-4c4b-82ec-f8050346e886	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	aee851cf-428e-4d29-a281-078fe00c56b0	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	9925773d-8ea1-4193-91e3-52cc1ce5ca67	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Sandoz Inc	13bd4214-9b7f-425b-af5f-fc1ddc678230	2024-02-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Bryant Ranch Prepack	c5d39ce2-8ae4-4bba-893f-a713afba1893	2023-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Asclemed USA, Inc.	f27237d7-123a-44ba-97df-b2446a94e3e5	2021-11-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076
Amoxicillin	AMOXICILLIN	Proficient Rx LP	9528a356-4101-4be2-a7e2-b0659e169e1a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064076 application number: ANDA064076

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMOXICILLIN	500 mg/1

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
308191	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
102c62ca-da20-4866-84a8-e3513824af4a	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
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
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
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
70518-2190-0	Amoxicillin	28 in 1 BLISTER PACK	CAPSULE	28	20
70518-2190-1	Amoxicillin	21 in 1 BLISTER PACK	CAPSULE	21	20
70518-2190-2	Amoxicillin	30 in 1 BLISTER PACK	CAPSULE	30	20
70518-2190-3	Amoxicillin	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	20
70518-2190-4	Amoxicillin	21 in 1 BOTTLE, PLASTIC	CAPSULE	21	20
70518-2190-5	Amoxicillin	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	20
70518-2190-6	Amoxicillin	1 in 1 POUCH	CAPSULE	1	20
70518-2190-7	Amoxicillin	100 in 1 BOX	CAPSULE	100	20
70518-2190-8	Amoxicillin	14 in 1 BOTTLE, PLASTIC	CAPSULE	14	20
70518-2190-9	Amoxicillin	40 in 1 BOTTLE, PLASTIC	CAPSULE	40	20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-2190-0	EA - Each	70518-2190	b6fab721-38de-48cf-a1aa-b1f5c9bbd749	1	2026-01-08
70518-2190-1	EA - Each	70518-2190	dc54739d-9e6e-469e-8082-8adee5e1abf8	1	2026-01-08
70518-2190-2	EA - Each	70518-2190	7238c2f1-7aa1-4869-89b5-776bea1e2d09	1	2026-01-08
70518-2190-3	EA - Each	70518-2190	989cfed3-0e5f-4206-97f4-bacd0bdc97a5	1	2026-01-08
70518-2190-4	EA - Each	70518-2190	8efd7b8a-e169-4021-a191-d6de7b509f03	1	2026-01-08
70518-2190-5	EA - Each	70518-2190	cf968363-6064-434e-9bb9-a0cf8cea9e25	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2190	AMOXICILLIN CAPSULE [REMEDYREPACK INC.]	14	Current NDC, Legacy NDC, 10 package rows	20250309_102c62ca-da20-4866-84a8-e3513824af4a.zip

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
308191	amoxicillin 500 MG Oral Capsule	PSN	102c62ca-da20-4866-84a8-e3513824af4a	20
308191	amoxicillin 500 MG Oral Capsule	SCD	102c62ca-da20-4866-84a8-e3513824af4a	20
308191	amoxicillin (as amoxicillin trihydrate) 500 MG Oral Capsule	SY	102c62ca-da20-4866-84a8-e3513824af4a	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2190-2	70518219002	30 CAPSULE in 1 BLISTER PACK (70518-2190-2)	30 capsule	2019-07-09	0000-00-00	No	No	Current