LANSOPRAZOLE

Product NDC: 16571-698
11-digit product format: 165710698
Labeler code: 16571
Product ID: 16571-698_348119f9-610e-46f1-affa-f9e68959b2f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LANSOPRAZOLE
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA201921
Marketing category: ANDA
Marketing start: 2020-11-01
Marketing end: 0000-00-00
Substance: LANSOPRAZOLE
Active strength: 30 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16571-698		D	Discontinued by firm	2026-08-17
excluded package	package	16571-698	16571-698-01	D	Discontinued by firm	2026-08-17
excluded package	package	16571-698	16571-698-03	D	Discontinued by firm	2026-08-17
excluded package	package	16571-698	16571-698-09	D	Discontinued by firm	2026-08-17
excluded package	package	16571-698	16571-698-50	D	Discontinued by firm	2026-08-17

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16571-698	16571-698-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16571-698	16571-698-09	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16571-698	16571-698-50	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A201921-001	LANSOPRAZOLE	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2012-12-18
A201921-002	LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2012-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201921-001	AB
A201921-002	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	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201921-001	LANSOPRAZOLE	15MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201921-002	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2012-12-18	`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	A201921-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A201921-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201921-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201921-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201921-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201921-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201921-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201921-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201921-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201921-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201921-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201921-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201921-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201921-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201921-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201921-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201921-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201921-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201921-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201921-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201921-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201921-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201921-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201921-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201921-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201921-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201921-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201921-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201921-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201921-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201921-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201921-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201921-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A201921-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201921-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A201921-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201921-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A201921-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201921-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A201921-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
d6b97638-59f4-48e2-8959-569628732c46	Product name	9	20210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04	Product name	2	20161206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16571-698-03	EA - Each	16571-698	00d488c8-9659-4035-b578-5dce6613c85f	1	2021-01-08
16571-698-09	EA - Each	16571-698	fa9367f4-ca0a-409c-8488-aa17de4f58b8	1	2021-01-08
16571-698-50	EA - Each	16571-698	3309fe7f-1632-44a4-9b34-85af8fda4521	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16571-698	LANSOPRAZOLE CAPSULE, DELAYED RELEASE [RISING PHARMA HOLDINGS, INC.]	2	Legacy NDC	20231103_348119f9-610e-46f1-affa-f9e68959b2f4.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
Lansoprazole	LANSOPRAZOLE	NuCare Pharmaceuticals,Inc.	136ad992-2e39-dad9-e063-6294a90adcc6	2024-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201921 application number: ANDA201921

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0K5C5T2QPG	LANSOPRAZOLE	103577-45-3	LANSOPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311277	lansoprazole 30 MG Delayed Release Oral Capsule	PSN	136ad992-2e39-dad9-e063-6294a90adcc6	1
311277	lansoprazole 30 MG Delayed Release Oral Capsule	SCD	136ad992-2e39-dad9-e063-6294a90adcc6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16571-698-01	16571069801	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-698-01)	2020-11-01	0000-00-00	No	No	Current
16571-698-03	16571069803	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-698-03)	2020-11-01	0000-00-00	No	No	Current
16571-698-09	16571069809	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-698-09)	2020-11-01	0000-00-00	No	No	Current
16571-698-50	16571069850	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16571-698-50)	2020-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lansoprazole	Rising Pharma Holdings, Inc. \| Natco Pharma Limited-Pharma Division	2025-11-10	Human Prescription Drug Label	3
Lansoprazole	NuCare Pharmaceuticals,Inc.	2024-03-11	HUMAN PRESCRIPTION DRUG LABEL	1