Tetracycline Hydrochloride

Product NDC
63629-1501
11-digit product format
636291501
Labeler code
63629
Product ID
63629-1501_b4e872f7-3537-465c-a2b6-c6e43495197a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tetracycline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA060704
Marketing category
ANDA
Marketing start
2010-03-23
Marketing end
0000-00-00
Substance
TETRACYCLINE HYDROCHLORIDE
Active strength
250 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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-1501DDiscontinued by firm2026-08-17
excluded packagepackage63629-150163629-1501-1DDiscontinued by firm2026-08-17
excluded packagepackage63629-150163629-1501-2DDiscontinued by firm2026-08-17
excluded packagepackage63629-150163629-1501-3DDiscontinued by firm2026-08-17
excluded packagepackage63629-150163629-1501-4DDiscontinued by firm2026-08-17
excluded packagepackage63629-150163629-1501-5DDiscontinued by firm2026-08-17
excluded packagepackage63629-150163629-1501-6DDiscontinued by firm2026-08-17
excluded packagepackage63629-150163629-1501-7DDiscontinued by firm2026-08-17

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 2 · 120 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 packagepackage63629-1501-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1501-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1501-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1501-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1501-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1501-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1501-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1501-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1501-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1501-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1501-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1501-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1501-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1501-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1501-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1501-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1501-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1501-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1501-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1501-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1501-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1501-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1501-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1501-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1501-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1501-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1501-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1501-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1501-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1501-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1501-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1501-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1501-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1501-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1501-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1501-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1501-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1501-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1501-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1501-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1501-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1501-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1501-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1501-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1501-5302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1501-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1501-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1501-7302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1501-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1501-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1501-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1501-5ed331223b511…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…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1501-1EA - Each63629-150124c3abd1-f2e5-4704-9e7c-af82a672d91c12012-07-24
63629-1501-2EA - Each63629-150128dee85c-5256-4db2-844a-ce99d093e28c12012-07-24
63629-1501-3EA - Each63629-150192babbf0-62a4-457b-ac8e-44129af3f91612012-07-24
63629-1501-4EA - Each63629-1501a190d8f8-ce0f-42b3-a1c2-e3b3875fb9a612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TETRACYCLINE HYDROCHLORIDEACTIVE INGREDIENTP6R62377KVTETRACYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
TETRACYCLINEACTIVE MOIETYF8VB5M810TTETRACYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTETRACYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TETRACYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TETRACYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTETRACYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTETRACYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTETRACYCLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3