Home NDC 10544-590 Tetracycline Hydrochloride
Product NDC 10544-590
11-digit product format 105440590
Labeler code 10544
Product ID 10544-590_d10c81e5-ccfe-4977-9cb9-c7edcdda6dc8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tetracycline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Blenheim Pharmacal, Inc.
Application ANDA060704
Marketing category ANDA
Marketing start 2010-03-03
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 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 · 110 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A060704-001 TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 A060704-002 TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved 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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A060704-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL Approved before 1982 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A060704-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL Approved before 1982 bb7c543d1eb4…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10544-590-28 Tetracycline Hydrochloride 28 in 1 BOTTLE CAPSULE 28 1 10544-590-30 Tetracycline Hydrochloride 30 in 1 BOTTLE CAPSULE 30 1 10544-590-60 Tetracycline Hydrochloride 60 in 1 BOTTLE CAPSULE 60 1 10544-590-90 Tetracycline Hydrochloride 90 in 1 BOTTLE CAPSULE 90 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Tetracycline Hydrochloride ACTIVE INGREDIENT P6R62377KV TETRACYCLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 TETRACYCLINE ACTIVE MOIETY F8VB5M810T TETRACYCLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TETRACYCLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TETRACYCLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TETRACYCLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TETRACYCLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TETRACYCLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TETRACYCLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TETRACYCLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10544-590 TETRACYCLINE HYDROCHLORIDE CAPSULE [BLENHEIM PHARMACAL, INC.] 1 Legacy NDC, 4 package rows 20100421_d07410b3-37e6-4382-97de-0c2676bc1103.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 10544-590-28 10544059028 28 in 1 BOTTLE Historical 10544-590-30 10544059030 30 in 1 BOTTLE Historical 10544-590-60 10544059060 60 in 1 BOTTLE Historical 10544-590-90 10544059090 90 in 1 BOTTLE Historical