Tetracycline Hydrochloride

Product NDC
52959-336
11-digit product format
529590336
Labeler code
52959
Product ID
52959-336_b921807d-5d59-4548-af3c-4152820b1465
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA060704
Marketing category
ANDA
Marketing start
2010-03-23
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-336IInactivated by FDA2026-08-17
excluded packagepackage52959-33652959-336-14IInactivated by FDA2026-08-17
excluded packagepackage52959-33652959-336-20IInactivated by FDA2026-08-17
excluded packagepackage52959-33652959-336-28IInactivated by FDA2026-08-17
excluded packagepackage52959-33652959-336-30IInactivated by FDA2026-08-17
excluded packagepackage52959-33652959-336-40IInactivated by FDA2026-08-17
excluded packagepackage52959-33652959-336-56IInactivated by FDA2026-08-17
excluded packagepackage52959-33652959-336-90IInactivated by FDA2026-08-17

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 3 · 168 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-336-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-336-56d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-336-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-336-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-336-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-336-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage52959-336-40d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-336-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-336-56f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-336-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-336-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-336-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-336-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage52959-336-40f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-336-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-336-562ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-336-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-336-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-336-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-336-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage52959-336-402ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-336-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-336-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-336-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-336-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-336-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-336-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage52959-336-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-336-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-336-56cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-336-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-336-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-336-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-336-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage52959-336-40cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-336-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-336-56cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-336-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-336-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-336-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-336-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage52959-336-40cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-336-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-336-56302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-336-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-336-28302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-336-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-336-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage52959-336-40302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-336-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-336-56ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage52959-336-14ed331223b511…672a5bd82f5f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A060704-001TETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982
A060704-002TETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A060704-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALApproved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A060704-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALApproved before 1982bb7c543d1eb4…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
151122cd-8b80-4972-8b02-3a4dda642fbcProduct name220200701
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-336-14Tetracycline Hydrochloride14 in 1 BOTTLE, PLASTICCAPSULE141
52959-336-20Tetracycline Hydrochloride20 in 1 BOTTLE, PLASTICCAPSULE201
52959-336-28Tetracycline Hydrochloride28 in 1 BOTTLE, PLASTICCAPSULE281
52959-336-30Tetracycline Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301
52959-336-40Tetracycline Hydrochloride40 in 1 BOTTLE, PLASTICCAPSULE401
52959-336-56Tetracycline Hydrochloride56 in 1 BOTTLE, PLASTICCAPSULE561
52959-336-90Tetracycline Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-336-14EA - Each52959-336f3b98929-95a8-44a7-90db-a6f21764ea4612013-02-13
52959-336-20EA - Each52959-33617c66c4d-5884-4db4-9139-5c732c0da71212013-02-13
52959-336-28EA - Each52959-3368a5a2afc-13e8-4645-b072-4d8dcd7a072812013-02-13
52959-336-30EA - Each52959-336a228392b-cc2c-417a-9937-f217adffa84412013-02-13
52959-336-40EA - Each52959-3366656490a-2fb5-4dc3-aedf-08d72d88467912013-02-13
52959-336-56EA - Each52959-336b4e9e955-18aa-44a0-b3a0-5230df6526ef12013-02-13
52959-336-90EA - Each52959-336b7bcedf7-2cdd-4aa7-bf57-fec8df353fcd12013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-336TETRACYCLINE HYDROCHLORIDE CAPSULE [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 7 package rows20120829_54d1720d-edfc-4eb4-8388-f61bd5971336.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198252tetracycline HCl 500 MG Oral CapsulePSN54d1720d-edfc-4eb4-8388-f61bd59713361
198252tetracycline hydrochloride 500 MG Oral CapsuleSCD54d1720d-edfc-4eb4-8388-f61bd59713361
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSY54d1720d-edfc-4eb4-8388-f61bd59713361
198252tetracycline HCl 500 MG Oral CapsuleSY54d1720d-edfc-4eb4-8388-f61bd59713361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-336-145295903361414 in 1 BOTTLE, PLASTICHistorical
52959-336-205295903362020 in 1 BOTTLE, PLASTICHistorical
52959-336-285295903362828 in 1 BOTTLE, PLASTICHistorical
52959-336-305295903363030 in 1 BOTTLE, PLASTICHistorical
52959-336-405295903364040 in 1 BOTTLE, PLASTICHistorical
52959-336-565295903365656 in 1 BOTTLE, PLASTICHistorical
52959-336-905295903369090 in 1 BOTTLE, PLASTICHistorical