tetracycline hydrochloride

Product NDC
23155-017
11-digit product format
231550017
Labeler code
23155
Product ID
23155-017_0d5bebf0-11ec-4572-9728-d8721296b1f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tetracycline hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
NDA050278
Marketing category
NDA
Marketing start
2024-09-15
Substance
TETRACYCLINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Tetracycline-class Antimicrobial [EPC], Tetracyclines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct23155-017DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage23155-01723155-017-01DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N050278-001ACHROMYCIN VTETRACYCLINE HYDROCHLORIDE500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 1982
N050278-003ACHROMYCIN VTETRACYCLINE HYDROCHLORIDE250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N050278-001AB
N050278-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N050278-001ACHROMYCIN V500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050278-003ACHROMYCIN V250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050278-001ACHROMYCIN V500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050278-003ACHROMYCIN V250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N050278-001ACHROMYCIN V500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050278-003ACHROMYCIN V250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050278-001ACHROMYCIN V500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050278-003ACHROMYCIN V250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050278-001ACHROMYCIN V500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050278-003ACHROMYCIN V250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050278-001ACHROMYCIN V500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050278-003ACHROMYCIN V250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050278-001ACHROMYCIN V500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050278-003ACHROMYCIN V250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050278-001ACHROMYCIN V500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N050278-003ACHROMYCIN V250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050278-001ACHROMYCIN V500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050278-003ACHROMYCIN V250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALABRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N050278-001ACHROMYCIN V500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N050278-003ACHROMYCIN V250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050278-001ACHROMYCIN V500MGCAPSULE / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N050278-003ACHROMYCIN V250MGCAPSULE / ORALRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050278-001ACHROMYCIN V500MGCAPSULE / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N050278-003ACHROMYCIN V250MGCAPSULE / ORALRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050278-001ACHROMYCIN V500MGCAPSULE / ORALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N050278-003ACHROMYCIN V250MGCAPSULE / ORALRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N050278-001ACHROMYCIN V500MGCAPSULE / ORALRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N050278-003ACHROMYCIN V250MGCAPSULE / ORALRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050278-001ACHROMYCIN V500MGCAPSULE / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050278-003ACHROMYCIN V250MGCAPSULE / ORALABRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050278-001ACHROMYCIN V500MGCAPSULE / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050278-003ACHROMYCIN V250MGCAPSULE / ORALABRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050278-001ACHROMYCIN V500MGCAPSULE / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050278-003ACHROMYCIN V250MGCAPSULE / ORALABRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050278-001ACHROMYCIN V500MGCAPSULE / ORALABRLD, RS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050278-003ACHROMYCIN V250MGCAPSULE / ORALABRLD, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050278-001ACHROMYCIN V500MGCAPSULE / ORALABRLD, RS, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050278-003ACHROMYCIN V250MGCAPSULE / ORALABRLD, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050278-001ACHROMYCIN V500MGCAPSULE / ORALABRLD, RS, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N050278-003ACHROMYCIN V250MGCAPSULE / ORALABRLD, Approved before 1982782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N050278-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N050278-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050278-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N050278-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N050278-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N050278-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050278-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N050278-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050278-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N050278-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050278-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N050278-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050278-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N050278-003AB12680178bc6a6…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050278-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N050278-003AB1d8e5a09893c0…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050278-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N050278-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N050278-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N050278-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N050278-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N050278-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N050278-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N050278-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N050278-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N050278-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N050278-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N050278-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050278-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N050278-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N050278-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N050278-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N050278-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12N050278-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N050278-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11N050278-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N050278-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12N050278-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N050278-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09N050278-003AB1b00525d2431f…

Additional Listing Data#

Finished product
Yes
Brand name base
tetracycline hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TETRACYCLINE HYDROCHLORIDE250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P6R62377KVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198250Internal RxNorm lookup
198252Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eaa5b1bd-0927-46e4-b941-32fcc492d258Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-017-01tetracycline hydrochloride100 in 1 BOTTLECAPSULE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-017-01EA - Each23155-01700238ee3-6b22-443f-9cb8-1639e42d3e5f12013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENTP6R62377KVTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
TETRACYCLINEACTIVE MOIETYF8VB5M810TTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
GELATININACTIVE INGREDIENT2G86QN327LTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-017TETRACYCLINE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 1 package rows20250406_eaa5b1bd-0927-46e4-b941-32fcc492d258.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
tetracycline hydrochlorideTETRACYCLINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.eaa5b1bd-0927-46e4-b941-32fcc492d2582025-03-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 050278
application number: NDA050278
ndc (product): 23155-017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198250tetracycline HCl 250 MG Oral CapsulePSNeaa5b1bd-0927-46e4-b941-32fcc492d25811
198252tetracycline HCl 500 MG Oral CapsulePSNeaa5b1bd-0927-46e4-b941-32fcc492d25811
198250tetracycline hydrochloride 250 MG Oral CapsuleSCDeaa5b1bd-0927-46e4-b941-32fcc492d25811
198252tetracycline hydrochloride 500 MG Oral CapsuleSCDeaa5b1bd-0927-46e4-b941-32fcc492d25811
198252tetracycline (as tetracycline hydrochloride) 500 MG Oral CapsuleSYeaa5b1bd-0927-46e4-b941-32fcc492d25811
198252tetracycline HCl 500 MG Oral CapsuleSYeaa5b1bd-0927-46e4-b941-32fcc492d25811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-017-0123155001701100 CAPSULE in 1 BOTTLE (23155-017-01) 100 capsule2024-09-150000-00-00NoNoCurrent
23155-017-10231550017101000 CAPSULE in 1 BOTTLE (23155-017-10) 1000 capsule2013-10-180000-00-00NoNoCurrent