Mefloquine Hydrochloride

Product NDC: 21695-449
11-digit product format: 216950449
Labeler code: 21695
Product ID: 21695-449_66091ee0-343a-4a04-a61e-86449943bc36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Mefloquine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA076392
Marketing category: ANDA
Marketing start: 2003-12-29
Marketing end: 0000-00-00
Substance: MEFLOQUINE HYDROCHLORIDE
Active strength: 250 mg/1
Pharmacologic classes: Antimalarial [EPC]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	21695-449		I	Inactivated by FDA	2026-10-05
excluded package	package	21695-449	21695-449-07	I	Inactivated by FDA	2026-10-05
excluded package	package	21695-449	21695-449-25	I	Inactivated by FDA	2026-10-05

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 2 · 66 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	21695-449-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-449-25	`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	21695-449-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-449-25	`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	21695-449-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-449-25	`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	21695-449-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-449-25	`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	21695-449-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-449-25	`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	21695-449-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-449-25	`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	21695-449-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-449-25	`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	21695-449-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-449-25	`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	21695-449-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-449-25	`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	21695-449-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-449-25	`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	21695-449-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-449-25	`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	21695-449-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-449-25	`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	21695-449-07	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-449-25	`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	21695-449-07	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-449-25	`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	21695-449-07	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-449-25	`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	21695-449-07	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-449-25	`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	21695-449-07	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-449-25	`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	21695-449-07	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-449-25	`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	21695-449-07	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-449-25	`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	21695-449-07	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-449-25	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076392-001	MEFLOQUINE HYDROCHLORIDE	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076392-001	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 2 · 43 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
2026-09-14 22:38:34	2026-08	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		RS	2003-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		RS	2003-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		RS	2003-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		RS	2003-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076392-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076392-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076392-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076392-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076392-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076392-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076392-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076392-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076392-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076392-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076392-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076392-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076392-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076392-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076392-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076392-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076392-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076392-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076392-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076392-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076392-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076392-001	AB	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A076392-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076392-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076392-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076392-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076392-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076392-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076392-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076392-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076392-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076392-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076392-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076392-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076392-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076392-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076392-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076392-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076392-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3f2d0ecd-4f7a-6e8c-a65e-58190a1c95df	Product name	2	20201015

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-449-07	2019-09-24	C162847	48780-1	934fe258-497a-48b1-e053-8cdaa90a720a	MEFLOQUINE HYDROCHLORIDE TABLETS
21695-449-25	2019-09-24	C162847	48780-1	934fe258-497a-48b1-e053-8cdaa90a720a	MEFLOQUINE HYDROCHLORIDE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-449-07	Mefloquine Hydrochloride	7 in 1 BOTTLE	TABLET	7		2
21695-449-25	Mefloquine Hydrochloride	25 in 1 BOTTLE	TABLET	25		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-449-07	EA - Each	21695-449	6f945adf-16a1-4003-8719-852c349b797f	1	2012-07-24
21695-449-25	EA - Each	21695-449	158685f7-afd6-4b35-ae71-8d1d0324db5d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
mefloquine hydrochloride	ACTIVE INGREDIENT	5Y9L3636O3	MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
mefloquine	ACTIVE MOIETY	TML814419R	MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
POLOXAMER 124	INACTIVE INGREDIENT	1S66E28KXA	MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-449	MEFLOQUINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	2	Legacy NDC, 2 package rows	20110517_57ca7bc4-e1a4-4a09-82bd-8b455e5ec3e4.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
Mefloquine Hydrochloride	MEFLOQUINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	09716a24-d7da-42b2-af29-c03a1b6670bd	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076392 application number: ANDA076392
Mefloquine Hydrochloride	MEFLOQUINE HYDROCHLORIDE	A-S Medication Solutions	9cbe26c7-7313-4cd6-9514-9190af1de763	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076392 application number: ANDA076392

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5Y9L3636O3	MEFLOQUINE HYDROCHLORIDE	51773-92-3	MEFLOQUINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
835913	mefloquine HCl 250 MG Oral Tablet	PSN	57ca7bc4-e1a4-4a09-82bd-8b455e5ec3e4	2
835913	mefloquine hydrochloride 250 MG Oral Tablet	SCD	57ca7bc4-e1a4-4a09-82bd-8b455e5ec3e4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-449-07	21695044907	7 in 1 BOTTLE	Historical
21695-449-25	21695044925	25 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MEFLOQUINE HYDROCHLORIDE TABLETS	Rebel Distributors Corp	2010-12-28	HUMAN PRESCRIPTION DRUG LABEL	2