Tetracycline Hydrochloride

Product NDC: 53808-0877
11-digit product format: 538080877
Labeler code: 53808
Product ID: 53808-0877_2c92f80c-2f2d-472c-9937-ee9c4e6ab1a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tetracycline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: State of Florida DOH Central Pharmacy
Application: ANDA061837
Marketing category: ANDA
Marketing start: 2013-01-01
Marketing end: 0000-00-00
Substance: TETRACYCLINE HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
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	53808-0877		I	Inactivated by FDA		2026-08-17
excluded package	package	53808-0877	53808-0877-2	I	Inactivated by FDA		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 · 42 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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`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	53808-0877-2	`9bebd1f3094a…`	`5416666fcb17…`

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
A061837-001	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982
A061837-002	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A061837-001	AB
A061837-002	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	RLD / RS	Source SHA-256
2026-08-18 06:07:40	2026-07	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061837-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061837-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	Approved before 1982	`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	A061837-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A061837-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A061837-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A061837-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061837-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A061837-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A061837-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A061837-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061837-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A061837-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061837-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A061837-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061837-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A061837-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061837-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A061837-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061837-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A061837-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061837-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A061837-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A061837-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A061837-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061837-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A061837-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061837-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A061837-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061837-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A061837-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A061837-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A061837-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061837-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A061837-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A061837-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A061837-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A061837-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A061837-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A061837-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A061837-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A061837-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A061837-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
151122cd-8b80-4972-8b02-3a4dda642fbc	Product name	2	20200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0877-2	2020-01-31	C162847	48780-1	9d75b9d0-7b4c-f424-e053-dadaa90a57ce	TETRACYCLINE HYDROCHLORIDE CAPSULES, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0877-2	Tetracycline Hydrochloride	60 in 1 BLISTER PACK	CAPSULE	60		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TETRACYCLINE HYDROCHLORIDE	ACTIVE INGREDIENT	P6R62377KV	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TETRACYCLINE	ACTIVE MOIETY	F8VB5M810T	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	IDK7C2HS09	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TETRACYCLINE HYDROCHLORIDE CAPSULE [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
53808-0877	TETRACYCLINE HYDROCHLORIDE CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20140415_edf54a38-41a7-42ec-a05f-46ab20cb6fc3.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
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Actavis Pharma, Inc.	32a409a0-fea6-411a-8218-c1c7df46d664	2025-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061837 application number: ANDA061837
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	4202cbfb-52e9-47f2-bd3a-1003319ca3cb	2025-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 061837 application number: ANDA061837

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
P6R62377KV	TETRACYCLINE HYDROCHLORIDE	64-75-5	TETRACYCLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198252	tetracycline HCl 500 MG Oral Capsule	PSN	edf54a38-41a7-42ec-a05f-46ab20cb6fc3	1
198252	tetracycline hydrochloride 500 MG Oral Capsule	SCD	edf54a38-41a7-42ec-a05f-46ab20cb6fc3	1
198252	tetracycline (as tetracycline hydrochloride) 500 MG Oral Capsule	SY	edf54a38-41a7-42ec-a05f-46ab20cb6fc3	1
198252	tetracycline HCl 500 MG Oral Capsule	SY	edf54a38-41a7-42ec-a05f-46ab20cb6fc3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0877-2	53808087702	60 in 1 BLISTER PACK	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TETRACYCLINE HYDROCHLORIDE CAPSULES, USP	State of Florida DOH Central Pharmacy	2013-09-30	HUMAN PRESCRIPTION DRUG LABEL	1