Ampicillin

Product NDC: 0781-2144
11-digit product format: 007812144
Labeler code: 0781
Product ID: 0781-2144_e8f470a8-ec75-4c1e-84d8-766372f61cf3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ampicillin
Dosage form: CAPSULE
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA064082
Marketing category: ANDA
Marketing start: 1995-08-29
Marketing end: 0000-00-00
Substance: AMPICILLIN TRIHYDRATE
Active strength: 250 mg/1
Pharmacologic classes: Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0781-2144		D	Discontinued by firm	2026-08-10
excluded package	package	0781-2144	0781-2144-01	D	Discontinued by firm	2026-08-10
excluded package	package	0781-2144	0781-2144-05	D	Discontinued by firm	2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-2144-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0781-2144-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-2144-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0781-2144-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0781-2144-05	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0781-2144-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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…`

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#

NDC, Effective, Related label table
NDC	Effective	Related label
0781-2144-01	2025-07-30	Ampicillin Capsules, USP
0781-2144-05	2025-07-30	Ampicillin Capsules, USP
0781-2144-01	2020-07-20	Ampicillin Capsules, USP
0781-2144-05	2020-07-20	Ampicillin Capsules, USP
0781-2144-01	2020-01-31	Ampicillin Capsules, USP
0781-2144-05	2020-01-31	Ampicillin Capsules, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0781-2144-01	Ampicillin	100 in 1 BOTTLE	CAPSULE	100		18
0781-2144-05	Ampicillin	500 in 1 BOTTLE	CAPSULE	500		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-2144-01	EA - Each	0781-2144	b746cebb-1126-4b6f-9c50-927c7c9dd431	1	2012-07-24
0781-2144-05	EA - Each	0781-2144	8968b407-9184-42ff-9e2b-8d2d460f7a9c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMPICILLIN TRIHYDRATE	ACTIVE INGREDIENT	HXQ6A1N7R6	AMPICILLIN CAPSULE [SANDOZ INC]	12
AMPICILLIN	ACTIVE MOIETY	7C782967RD	AMPICILLIN CAPSULE [SANDOZ INC]	12
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	AMPICILLIN CAPSULE [SANDOZ INC]	12
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMPICILLIN CAPSULE [SANDOZ INC]	12
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMPICILLIN CAPSULE [SANDOZ INC]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMPICILLIN CAPSULE [SANDOZ INC]	12
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	AMPICILLIN CAPSULE [SANDOZ INC]	12
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	AMPICILLIN CAPSULE [SANDOZ INC]	12
SHELLAC	INACTIVE INGREDIENT	46N107B71O	AMPICILLIN CAPSULE [SANDOZ INC]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMPICILLIN CAPSULE [SANDOZ INC]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-2144	AMPICILLIN CAPSULE [SANDOZ INC]	17	Legacy NDC, 2 package rows	20240514_0a66c5c3-63bf-46e3-835e-26b555ab6954.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
Ampicillin	AMPICILLIN	Sandoz Inc	0a66c5c3-63bf-46e3-835e-26b555ab6954	2025-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064082 application number: ANDA064082 ndc (product): 0781-2144

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
313800	ampicillin 250 MG Oral Capsule	PSN	0a66c5c3-63bf-46e3-835e-26b555ab6954	18
308212	ampicillin 500 MG Oral Capsule	PSN	0a66c5c3-63bf-46e3-835e-26b555ab6954	18
313800	ampicillin 250 MG Oral Capsule	SCD	0a66c5c3-63bf-46e3-835e-26b555ab6954	18
308212	ampicillin 500 MG Oral Capsule	SCD	0a66c5c3-63bf-46e3-835e-26b555ab6954	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-2144-01	00781214401	100 CAPSULE in 1 BOTTLE (0781-2144-01)	100 capsule	1995-08-29	0000-00-00	No	No	Current
0781-2144-05	00781214405	500 CAPSULE in 1 BOTTLE (0781-2144-05)	500 capsule	1995-08-29	0000-00-00	No	No	Current