Zmax

Product NDC: 21695-444
11-digit product format: 216950444
Labeler code: 21695
Product ID: 21695-444_c61229e8-75cb-4776-9883-c5630bc38a32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: azithromycin
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA050797
Marketing category: NDA
Marketing start: 1995-06-10
Marketing end: 0000-00-00
Substance: AZITHROMYCIN
Active strength: 2 g/60mL
Pharmacologic classes: Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]
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	21695-444		I	Inactivated by FDA		2026-08-11
excluded package	package	21695-444	21695-444-60	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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`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	21695-444-60	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N050797-001	ZMAX	AZITHROMYCIN	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL		RLD	2005-06-10

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N050797-001	ZMAX	EQ 2GM BASE/BOT	FOR SUSPENSION, EXTENDED RELEASE / ORAL	RLD	2005-06-10	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050797-001	6984403	2024-02-14	U-282	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050797-001	6984403	2024-02-14	U-282	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050797-001	6984403	2024-02-14	U-282	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050797-001	6984403	2024-02-14	U-282	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050797-001	6984403	2024-02-14	U-282	Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050797-001	6984403	2024-02-14	U-282	Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050797-001	6984403	2024-02-14	U-282	Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050797-001	6984403	2024-02-14	U-282	Drug product		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050797-001	6984403	2024-02-14	U-282	Drug product		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050797-001	6984403	2024-02-14	U-282	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050797-001	6984403	2024-02-14	U-282	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050797-001	6984403	2024-02-14	U-282	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050797-001	6984403	2024-02-14	U-282	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050797-001	6984403	2024-02-14	U-282	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050797-001	6984403	2024-02-14	U-282	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050797-001	6984403	2024-02-14	U-282	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050797-001	6984403	2024-02-14	U-282	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050797-001	6984403	2024-02-14	U-282	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050797-001	6984403	2024-02-14	U-282	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050797-001	6984403	2024-02-14	U-282	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050797-001	7887844	2024-02-14		Drug product	2011-03-15	`3f01610625f2…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-444-60	2019-09-24	C162847	48780-1	934fe258-498f-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use ZMAX safely and effectively. See full prescribing information for ZMAX. ZMAX (azithromycin) powder, for suspension for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-444-60	Zmax	60 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	60		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
azithromycin	ACTIVE INGREDIENT	F94OW58Y8V	ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
azithromycin	ACTIVE MOIETY	F94OW58Y8V	ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
glyceryl behenate	INACTIVE INGREDIENT	R8WTH25YS2	ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
magnesium hydroxide	INACTIVE INGREDIENT	NBZ3QY004S	ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
poloxamer 407	INACTIVE INGREDIENT	TUF2IVW3M2	ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
sodium phosphate, tribasic anhydrous	INACTIVE INGREDIENT	SX01TZO3QZ	ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
sucrose	INACTIVE INGREDIENT	C151H8M554	ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-444	ZMAX (AZITHROMYCIN) POWDER, FOR SUSPENSION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110127_c61229e8-75cb-4776-9883-c5630bc38a32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
577378	azithromycin 2 GM in 60 mL Extended Release Oral Suspension	PSN	c61229e8-75cb-4776-9883-c5630bc38a32	1
583482	Zmax 2 GM in 60 mL Extended Release Oral Suspension	PSN	c61229e8-75cb-4776-9883-c5630bc38a32	1
583482	azithromycin 33.3 MG/ML Extended Release Suspension [Zmax]	SBD	c61229e8-75cb-4776-9883-c5630bc38a32	1
577378	azithromycin 33.3 MG/ML Extended Release Suspension	SCD	c61229e8-75cb-4776-9883-c5630bc38a32	1
577378	azithromycin 2 GM per 60 ML Extended Release Suspension	SY	c61229e8-75cb-4776-9883-c5630bc38a32	1
583482	Zmax 2 GM per 60 ML Extended Release Suspension	SY	c61229e8-75cb-4776-9883-c5630bc38a32	1
583482	Zmax 33.3 MG/ML Extended Release Suspension	SY	c61229e8-75cb-4776-9883-c5630bc38a32	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-444-60	21695044460	60 mL in 1 BOTTLE	60 ml	Historical