Tetracycline Hydrochloride

Product NDC: 82804-292
11-digit product format: 828040292
Labeler code: 82804
Product ID: 82804-292_d48071a0-c397-42f8-b8ad-158282e745e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tetracycline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA062752
Marketing category: ANDA
Marketing start: 2020-04-01
Substance: TETRACYCLINE HYDROCHLORIDE
Active strength: 500 mg/1
Pharmacologic classes: Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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
A062752-001	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB		1988-08-12
A062752-002	TETRACYCLINE HYDROCHLORIDE	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB		1988-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A062752-001	AB
A062752-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062752-001	TETRACYCLINE HYDROCHLORIDE	250MG	CAPSULE / ORAL	AB	1988-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062752-002	TETRACYCLINE HYDROCHLORIDE	500MG	CAPSULE / ORAL	AB	1988-08-12	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A062752-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A062752-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062752-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A062752-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062752-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A062752-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062752-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062752-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062752-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A062752-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062752-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062752-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062752-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062752-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062752-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062752-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062752-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062752-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062752-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062752-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062752-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062752-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062752-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A062752-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062752-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062752-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062752-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062752-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062752-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062752-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062752-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A062752-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062752-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062752-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062752-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A062752-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062752-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A062752-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062752-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A062752-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Tetracycline Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TETRACYCLINE HYDROCHLORIDE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
P6R62377KV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198252	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d48071a0-c397-42f8-b8ad-158282e745e3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82804-292-56	Tetracycline Hydrochloride	56 in 1 BOTTLE	CAPSULE	56		1

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	02e88b4a-57ae-4ef6-ba48-97c657202b94	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062752 application number: ANDA062752
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc. .	ccd30048-a226-455f-971b-5dbf14b22e9d	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062752 application number: ANDA062752
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Bryant Ranch Prepack	22208459-3e6f-46a7-9f7f-f2c254a38132	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062752 application number: ANDA062752
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Proficient Rx LP	d48071a0-c397-42f8-b8ad-158282e745e3	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062752 application number: ANDA062752 ndc (product): 82804-292
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	3ce3e8dc-7fbd-4f8d-a65f-092e1ef21725	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062752 application number: ANDA062752
Tetracycline Hydrochloride	TETRACYCLINE HYDROCHLORIDE	Chartwell RX, LLC.	aa30113f-ab58-4f41-82c1-2fcb540d4a82	2023-07-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 062752 application number: ANDA062752

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	d48071a0-c397-42f8-b8ad-158282e745e3	1
198252	tetracycline hydrochloride 500 MG Oral Capsule	SCD	d48071a0-c397-42f8-b8ad-158282e745e3	1
198252	tetracycline (as tetracycline hydrochloride) 500 MG Oral Capsule	SY	d48071a0-c397-42f8-b8ad-158282e745e3	1
198252	tetracycline HCl 500 MG Oral Capsule	SY	d48071a0-c397-42f8-b8ad-158282e745e3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-292-56	82804029256	56 CAPSULE in 1 BOTTLE (82804-292-56)	56 capsule	2026-05-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tetracycline Hydrochloride Capsules, USP For Oral Use Rx Only	Proficient Rx LP	2026-05-01	HUMAN PRESCRIPTION DRUG LABEL	1