Ampicillin

Product NDC: 70518-2607
11-digit product format: 705182607
Labeler code: 70518
Product ID: 70518-2607_4faa3c23-9796-a19e-e063-6294a90acf7e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ampicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA064082
Marketing category: ANDA
Marketing start: 2020-02-28
Substance: AMPICILLIN TRIHYDRATE
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2607	70518-2607-0	D	Discontinued by firm		2026-08-10

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
A064082-001	AMPICILLIN TRIHYDRATE	AMPICILLIN/AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29
A064082-002	AMPICILLIN TRIHYDRATE	AMPICILLIN/AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064082-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB	RS	1995-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL	AB		1995-08-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL	AB		1995-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064082-001	AMPICILLIN TRIHYDRATE	EQ 250MG BASE	CAPSULE / ORAL			1995-08-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A064082-002	AMPICILLIN TRIHYDRATE	EQ 500MG BASE	CAPSULE / ORAL		RS	1995-08-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064082-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064082-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064082-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064082-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064082-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064082-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064082-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064082-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064082-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064082-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064082-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064082-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064082-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064082-002	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A064082-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A064082-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A064082-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A064082-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064082-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A064082-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064082-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A064082-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064082-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064082-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064082-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064082-002	AB	1	`a72a2bbeb626…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A064082-002	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMPICILLIN TRIHYDRATE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HXQ6A1N7R6	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308212	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
4134cd79-c895-4e6e-b1d5-8e01c38bf2d1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fd9d6ee0-43ae-43c7-aa52-3d5a936186d6	Product name	1	20250722
4fe9b92f-7dcd-4058-8def-e75f4dcd5ab3	Product name	2	20160201
c9385d77-2af7-47a4-bc97-1127e71caf9b	Product name	3	20160201
05b6b9ae-4ba4-27ee-4c8c-f72b41de3815	Product name	5	20151207
b353113e-7b3d-4b1f-a286-b96a3a5eac85	Product name	3	20151026
8c59be9b-72b0-49e8-b7ef-1a80c10599de	Product name	3	20150316

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-01-30	Ampicillin Capsules, USP
2022-01-30	Ampicillin Capsules, USP
2022-01-30	Ampicillin Capsules, USP
2022-01-28	Ampicillin Capsules, USP
2022-01-28	Ampicillin Capsules, USP
2022-01-28	Ampicillin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70518-2607-0	Ampicillin	28 in 1 BOTTLE, PLASTIC	CAPSULE	28		13
70518-2607-1	Ampicillin	28 in 1 BOTTLE, PLASTIC	CAPSULE	28		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-2607-0	EA - Each	70518-2607	c7cb81ab-5f2f-4a70-9a9b-10376da3893c	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-2607	AMPICILLIN CAPSULE [REMEDYREPACK INC.]	8	Current NDC, Legacy NDC, 2 package rows	20250322_4134cd79-c895-4e6e-b1d5-8e01c38bf2d1.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ampicillin	AMPICILLIN	REMEDYREPACK INC.	4134cd79-c895-4e6e-b1d5-8e01c38bf2d1	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064082 application number: ANDA064082 ndc (product): 70518-2607
Ampicillin	AMPICILLIN	Sandoz Inc	0a66c5c3-63bf-46e3-835e-26b555ab6954	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064082 application number: ANDA064082

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HXQ6A1N7R6	AMPICILLIN TRIHYDRATE	7177-48-2	AMPICILLIN TRIHYDRATE
7C782967RD	AMPICILLIN	69-53-4	Ampicillin

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308212	ampicillin 500 MG Oral Capsule	PSN	4134cd79-c895-4e6e-b1d5-8e01c38bf2d1	13
308212	ampicillin 500 MG Oral Capsule	SCD	4134cd79-c895-4e6e-b1d5-8e01c38bf2d1	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2607-0	70518260700	28 CAPSULE in 1 BOTTLE, PLASTIC (70518-2607-0)	28 capsule	2020-02-28	0000-00-00	No	No	Current
70518-2607-1	70518260701	28 CAPSULE in 1 BOTTLE, PLASTIC (70518-2607-1)	28 capsule	2025-07-17		No	No	Current