EPIVIR

Product NDC: 53808-0246
11-digit product format: 538080246
Labeler code: 53808
Product ID: 53808-0246_4e2ee289-a8d8-4d02-ac27-0a2a2d0bbe22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lamivudine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: NDA020564
Marketing category: NDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: LAMIVUDINE
Active strength: 300 mg/1
Pharmacologic classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0246		I	Inactivated by FDA		2026-08-11
excluded package	package	53808-0246	53808-0246-1	I	Inactivated by FDA		2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0246-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0246-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0246-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0246-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0246-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0246-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0246-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0246-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0246-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0246-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0246-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0246-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0246-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0246-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0246-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0246-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0246-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0246-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0246-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0246-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0246-1	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	53808-0246-1	`110d247fa046…`	`a55b01930146…`

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
N020564-001	EPIVIR	LAMIVUDINE	150MG	TABLET / ORAL	AB	RLD	1995-11-17
N020564-003	EPIVIR	LAMIVUDINE	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020564-001	AB
N020564-003	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	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020564-001	EPIVIR	150MG	TABLET / ORAL	AB	RLD	1995-11-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020564-003	EPIVIR	300MG	TABLET / ORAL	AB	RLD, RS	2002-06-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020564-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020564-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020564-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020564-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020564-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020564-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020564-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020564-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020564-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020564-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020564-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020564-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020564-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020564-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020564-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020564-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020564-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020564-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020564-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020564-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020564-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020564-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020564-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020564-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020564-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020564-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020564-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020564-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020564-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020564-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020564-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020564-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020564-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020564-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020564-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020564-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020564-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020564-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020564-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020564-003	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
aaa99659-c62c-7281-d402-9590409850c2	Product name	6	20260128
a02e6d35-8cc4-a80a-fd4d-d3ec16f69b8e	Product name	8	20250626
4ef90d80-1289-4267-a2bb-01c741d1208f	Product name	1	20230829
72dcca4e-6eae-4149-a92b-264c2a07004f	Product name	1	20230808
3832141c-c294-474a-9473-1052c891450e	Product name	2	20230105
320f244d-8b4e-4893-9f14-104b2a8e0aaf	Product name	2	20201007
7ff71f22-5b66-4a3d-bf64-671893a6409d	Product name	2	20201007
3644e9cf-6f4d-4b63-b875-6a4b5187c47e	Product name	1	20190703
0e579b5c-f0b5-e690-466e-4a5e809e2c68	Product name	3	20190627
6f122144-2ceb-48fa-a906-0d2eb742717e	Product name	1	20190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67	Product name	1	20181211
fbdbfbef-2c33-0298-4fef-f6693e670fe1	Product name	7	20181210
d07e0b9e-e041-41dc-942a-a2a6601dc221	Product name	1	20181029
af19b329-4f44-cd81-491a-fbb7fe7a079f	Product name	2	20151013
c873f14e-2add-4d53-b9b3-bf775efd3702	Product name	1	20150325

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0246-1	2019-10-21	C162847	48780-1	956f9ecf-d5c6-621f-e053-dbdaa90a74ad	These highlights do not include all the information needed to use EPIVIR safely and effectively. See full prescribing information for EPIVIR. EPIVIR (lamivudine) Tablets and Oral Solution Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0246-1	EPIVIR	30 in 1 BLISTER PACK	TABLET, FILM COATED	30		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LAMIVUDINE	ACTIVE INGREDIENT	2T8Q726O95	EPIVIR (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LAMIVUDINE	ACTIVE MOIETY	2T8Q726O95	EPIVIR (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	EPIVIR (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERRIC OXIDE BLACK	INACTIVE INGREDIENT	XM0M87F357	EPIVIR (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	EPIVIR (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EPIVIR (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	EPIVIR (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	EPIVIR (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	EPIVIR (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	EPIVIR (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0246	EPIVIR (LAMIVUDINE) TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20100526_13ca868d-a734-4c2f-88f0-ac1071ba7311.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
EPIVIR	LAMIVUDINE	ViiV Healthcare Company	89226149-47fa-4f7d-bb1f-1aa7034486b8	2024-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020564 application number: NDA020564

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2T8Q726O95	LAMIVUDINE	134678-17-4	LAMIVUDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
152931	Epivir 150 MG Oral Tablet	PSN	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
352230	Epivir 300 MG Oral Tablet	PSN	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
199147	lamiVUDine 150 MG Oral Tablet	PSN	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
349491	lamiVUDine 300 MG Oral Tablet	PSN	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
152931	lamivudine 150 MG Oral Tablet [Epivir]	SBD	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
352230	lamivudine 300 MG Oral Tablet [Epivir]	SBD	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
199147	lamivudine 150 MG Oral Tablet	SCD	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
349491	lamivudine 300 MG Oral Tablet	SCD	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
199147	3TC 150 MG Oral Tablet	SY	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
152931	3TC 150 MG Oral Tablet [Epivir]	SY	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
349491	3TC 300 MG Oral Tablet	SY	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
352230	3TC 300 MG Oral Tablet [Epivir]	SY	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
152931	Epivir 150 MG Oral Tablet	SY	13ca868d-a734-4c2f-88f0-ac1071ba7311	1
352230	Epivir 300 MG Oral Tablet	SY	13ca868d-a734-4c2f-88f0-ac1071ba7311	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0246-1	53808024601	30 in 1 BLISTER PACK	Historical