Tetracycline Hydrochloride

Product NDC
71335-2415
11-digit product format
713352415
Labeler code
71335
Product ID
71335-2415_cf243932-ea5b-4599-bfb0-cf85e5c9ab3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210662
Marketing category
ANDA
Marketing start
2019-01-18
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

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
A210662-001TETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-07
A210662-002TETRACYCLINE HYDROCHLORIDETETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210662-001AB
A210662-002AB

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 06:07:402026-07A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-07caaa826d4ba7…
2026-08-18 06:07:402026-07A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210662-001TETRACYCLINE HYDROCHLORIDE250MGCAPSULE / ORALAB2018-11-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210662-002TETRACYCLINE HYDROCHLORIDE500MGCAPSULE / ORALAB2018-11-07bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210662-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210662-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210662-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210662-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210662-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210662-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210662-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210662-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210662-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210662-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210662-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210662-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210662-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210662-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210662-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210662-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210662-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210662-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210662-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210662-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210662-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210662-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210662-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210662-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210662-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210662-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210662-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210662-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210662-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210662-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210662-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210662-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210662-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210662-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210662-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210662-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210662-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210662-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210662-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210662-002AB1bb7c543d1eb4…

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
58e4b5b3-e093-46e7-b28e-a2c4821c5b63Available 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
71335-2415-1Tetracycline Hydrochloride20 in 1 BOTTLECAPSULE20100
71335-2415-2Tetracycline Hydrochloride40 in 1 BOTTLECAPSULE40100
71335-2415-3Tetracycline Hydrochloride60 in 1 BOTTLECAPSULE60100
71335-2415-4Tetracycline Hydrochloride30 in 1 BOTTLECAPSULE30100
71335-2415-5Tetracycline Hydrochloride28 in 1 BOTTLECAPSULE28100
71335-2415-6Tetracycline Hydrochloride112 in 1 BOTTLECAPSULE112100
71335-2415-7Tetracycline Hydrochloride6 in 1 BOTTLECAPSULE6100
71335-2415-8Tetracycline Hydrochloride10 in 1 BOTTLECAPSULE10100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2415TETRACYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 8 package rows20241114_58e4b5b3-e093-46e7-b28e-a2c4821c5b63.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBreckenridge Pharmaceutical, Inc.00acf413-c5d2-4a54-9d0d-56266cbc9edc2026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210662
application number: ANDA210662
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBryant Ranch Prepack58e4b5b3-e093-46e7-b28e-a2c4821c5b632024-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210662
application number: ANDA210662
ndc (product): 71335-2415
Tetracycline HydrochlorideTETRACYCLINE HYDROCHLORIDEBryant Ranch Prepack2c9208db-5f4f-4382-854f-6786b1e458db2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210662
application number: ANDA210662

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198250tetracycline HCl 250 MG Oral CapsulePSN58e4b5b3-e093-46e7-b28e-a2c4821c5b63100
198250tetracycline hydrochloride 250 MG Oral CapsuleSCD58e4b5b3-e093-46e7-b28e-a2c4821c5b63100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2415-17133524150120 CAPSULE in 1 BOTTLE (71335-2415-1) 20 capsule2024-11-12NoNoCurrent
71335-2415-27133524150240 CAPSULE in 1 BOTTLE (71335-2415-2) 40 capsule2024-11-12NoNoCurrent
71335-2415-37133524150360 CAPSULE in 1 BOTTLE (71335-2415-3) 60 capsule2024-11-12NoNoCurrent
71335-2415-47133524150430 CAPSULE in 1 BOTTLE (71335-2415-4) 30 capsule2024-11-12NoNoCurrent
71335-2415-57133524150528 CAPSULE in 1 BOTTLE (71335-2415-5) 28 capsule2024-11-12NoNoCurrent
71335-2415-671335241506112 CAPSULE in 1 BOTTLE (71335-2415-6) 112 capsule2024-11-12NoNoCurrent
71335-2415-7713352415076 CAPSULE in 1 BOTTLE (71335-2415-7) 6 capsule2024-11-12NoNoCurrent
71335-2415-87133524150810 CAPSULE in 1 BOTTLE (71335-2415-8) 10 capsule2024-11-12NoNoCurrent