Tetracycline Hydrochloride

Product NDC
21695-640
11-digit product format
216950640
Labeler code
21695
Product ID
21695-640_5419f5dd-bf20-4eea-982d-33511a022c38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
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
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-640IInactivated by FDA2026-08-17
excluded packagepackage21695-64021695-640-28IInactivated by FDA2026-08-17
excluded packagepackage21695-64021695-640-30IInactivated by FDA2026-08-17
excluded packagepackage21695-64021695-640-40IInactivated by FDA2026-08-17
excluded packagepackage21695-64021695-640-42IInactivated by FDA2026-08-17
excluded packagepackage21695-64021695-640-56IInactivated by FDA2026-08-17
excluded packagepackage21695-64021695-640-90IInactivated 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 · 154 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 packagepackage21695-640-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-640-42d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-640-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-640-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-640-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-640-56d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-640-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-640-42f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-640-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-640-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-640-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-640-56f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-640-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-640-422ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-640-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-640-902ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-640-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-640-562ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-640-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-640-42a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-640-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-640-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-640-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-640-56a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-640-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-640-42cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-640-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-640-90cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-640-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-640-56cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-640-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-640-42cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-640-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-640-90cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-640-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-640-56cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-640-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-640-42302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-640-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-640-90302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-640-28302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-640-56302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-640-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-640-42ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-640-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-640-90ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-640-28ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-640-56ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-640-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-640-420efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-640-300efc9e666f02…f202fb6c5f17…

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
21695-640-28Tetracycline Hydrochloride28 in 1 BOTTLECAPSULE281
21695-640-30Tetracycline Hydrochloride30 in 1 BOTTLECAPSULE301
21695-640-40Tetracycline Hydrochloride40 in 1 BOTTLECAPSULE401
21695-640-42Tetracycline Hydrochloride42 in 1 BOTTLECAPSULE421
21695-640-56Tetracycline Hydrochloride56 in 1 BOTTLECAPSULE561
21695-640-90Tetracycline Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-640-28EA - Each21695-640ea7fa0a7-2350-4a60-9baa-341b4e800cc812012-07-24
21695-640-30EA - Each21695-640ceded485-9594-4426-9e51-e7c352c6f94112012-07-24
21695-640-40EA - Each21695-640f015c0a7-ea09-4484-b7d9-ad2529b8207212012-07-24
21695-640-56EA - Each21695-6407f6bf15d-dbc5-47da-aa32-69baa0bc3bce12012-07-24
21695-640-90EA - Each21695-6409e1d7c41-7a6a-45ac-99f6-17616bdae85812012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-640TETRACYCLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 6 package rows20101210_5419f5dd-bf20-4eea-982d-33511a022c38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198250tetracycline HCl 250 MG Oral CapsulePSN5419f5dd-bf20-4eea-982d-33511a022c381
198252tetracycline HCl 500 MG Oral CapsulePSN5419f5dd-bf20-4eea-982d-33511a022c381
198250tetracycline hydrochloride 250 MG Oral CapsuleSCD5419f5dd-bf20-4eea-982d-33511a022c381
198252tetracycline hydrochloride 500 MG Oral CapsuleSCD5419f5dd-bf20-4eea-982d-33511a022c381
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSY5419f5dd-bf20-4eea-982d-33511a022c381
198252tetracycline HCl 500 MG Oral CapsuleSY5419f5dd-bf20-4eea-982d-33511a022c381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-640-282169506402828 in 1 BOTTLEHistorical
21695-640-302169506403030 in 1 BOTTLEHistorical
21695-640-402169506404040 in 1 BOTTLEHistorical
21695-640-422169506404242 in 1 BOTTLEHistorical
21695-640-562169506405656 in 1 BOTTLEHistorical
21695-640-902169506409090 in 1 BOTTLEHistorical