Home NDC 51991-907 Tetracycline Hydrochloride
Product NDC 51991-907
11-digit product format 519910907
Labeler code 51991
Product ID 51991-907_a8cfae79-912a-40ad-99b3-02510f5b7bed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tetracycline Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Breckenridge Pharmaceutical, Inc.
Application ANDA210662
Marketing category ANDA
Marketing start 2019-01-18
Substance TETRACYCLINE HYDROCHLORIDE
Active strength 500 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210662-001 TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 A210662-002 TETRACYCLINE HYDROCHLORIDE TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210662-001 TETRACYCLINE HYDROCHLORIDE 250MG CAPSULE / ORAL AB 2018-11-07 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210662-002 TETRACYCLINE HYDROCHLORIDE 500MG CAPSULE / ORAL AB 2018-11-07 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tetracycline Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRACYCLINE HYDROCHLORIDE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P6R62377KV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198250 Internal RxNorm lookup 198252 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51991-907-01 Tetracycline Hydrochloride 100 in 1 BOTTLE, PLASTIC CAPSULE 100 8 51991-907-05 Tetracycline Hydrochloride 500 in 1 BOTTLE, PLASTIC CAPSULE 500 8 51991-907-33 Tetracycline Hydrochloride 30 in 1 BOTTLE, PLASTIC CAPSULE 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51991-907 TETRACYCLINE HYDROCHLORIDE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.] 7 Current NDC, Legacy NDC, 3 package rows 20240327_00acf413-c5d2-4a54-9d0d-56266cbc9edc.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51991-907-01 51991090701 100 CAPSULE in 1 BOTTLE, PLASTIC (51991-907-01) 100 capsule 2019-01-18 0000-00-00 No No Current 51991-907-05 51991090705 500 CAPSULE in 1 BOTTLE, PLASTIC (51991-907-05) 500 capsule 2019-01-18 0000-00-00 No No Current 51991-907-33 51991090733 30 CAPSULE in 1 BOTTLE, PLASTIC (51991-907-33) 30 capsule 2019-01-18 0000-00-00 No No Current