Demeclocycline Hydrochloride

Product NDC: 10135-626
11-digit product format: 101350626
Labeler code: 10135
Product ID: 10135-626_5862ef81-aa7c-4331-96d5-ebc9bc9458d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Demeclocycline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA065447
Marketing category: ANDA
Marketing start: 2016-07-01
Marketing end: 0000-00-00
Substance: DEMECLOCYCLINE HYDROCHLORIDE
Active strength: 300 mg/1
Pharmacologic classes: Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]
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	10135-626		I	Inactivated by FDA		2026-08-10
excluded package	package	10135-626	10135-626-48	I	Inactivated by FDA		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 · 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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-626-48	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-626-48	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-626-48	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-626-48	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-626-48	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-626-48	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-626-48	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-626-48	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-626-48	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-626-48	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-626-48	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-626-48	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-626-48	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-626-48	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-626-48	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10135-626-48	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10135-626-48	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10135-626-48	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10135-626-48	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10135-626-48	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
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	10135-626-48	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	10135-626-48	E	Excluded after deficient or non-compliant submission was not corrected	`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
A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB		2015-08-18
A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB		2015-08-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065447-001	AB
A065447-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065447-001	DEMECLOCYCLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2015-08-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065447-002	DEMECLOCYCLINE HYDROCHLORIDE	300MG	TABLET / ORAL	AB	2015-08-18	`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	A065447-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065447-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065447-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065447-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065447-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065447-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065447-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065447-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065447-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065447-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065447-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065447-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065447-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065447-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065447-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065447-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065447-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065447-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065447-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065447-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065447-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065447-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065447-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065447-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065447-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065447-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065447-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065447-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065447-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065447-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065447-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065447-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065447-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065447-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065447-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065447-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065447-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065447-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065447-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A065447-002	AB	1	`782e0a99824c…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
b5dbb1ae-e36f-978d-e5e0-8711031739bc	Product name	2	20150904

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10135-626-48	2020-01-31	C162847	48780-1	9d75b9d1-11c4-f424-e053-dadaa90a57ce	Demeclocycline Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10135-626-48	Demeclocycline Hydrochloride	48 in 1 BOTTLE	TABLET, FILM COATED	48		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10135-626-48	EA - Each	10135-626	a677826f-add2-4b8d-bcbb-2c216c6e494d	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-626	DEMECLOCYCLINE HYDROCHLORIDE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]	1	Legacy NDC, 1 package rows	20161006_10f80874-0289-4a23-8f42-b3e8fe43e1cb.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
Demeclocycline Hydrochloride	DEMECLOCYCLINE HYDROCHLORIDE	PuraCap Laboratories LLC	88e03cb0-25f5-41a5-b77f-58ab8f3be181	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065447 application number: ANDA065447
Demeclocycline Hydrochloride	DEMECLOCYCLINE HYDROCHLORIDE	Epic Pharma, LLC	645af8f4-0843-4afb-9ddc-f587f38adb68	2023-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065447 application number: ANDA065447

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
29O079NTYT	DEMECLOCYCLINE HYDROCHLORIDE	64-73-3	DEMECLOCYCLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
905341	demeclocycline HCl 150 MG Oral Tablet	PSN	10f80874-0289-4a23-8f42-b3e8fe43e1cb	1
905347	demeclocycline HCl 300 MG Oral Tablet	PSN	10f80874-0289-4a23-8f42-b3e8fe43e1cb	1
905341	demeclocycline hydrochloride 150 MG Oral Tablet	SCD	10f80874-0289-4a23-8f42-b3e8fe43e1cb	1
905347	demeclocycline hydrochloride 300 MG Oral Tablet	SCD	10f80874-0289-4a23-8f42-b3e8fe43e1cb	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
10135-626-48	10135062648	48 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Demeclocycline Hydrochloride Tablets	Marlex Pharmaceuticals Inc	2016-07-01	HUMAN PRESCRIPTION DRUG LABEL	1