Home NDC 82449-802 Rifampin
Product NDC 82449-802
11-digit product format 824490802
Labeler code 82449
Product ID 82449-802_d53a0c06-47d1-37c6-e053-2a95a90af9e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rifampin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler STERISCIENCE SPECIALTIES PRIVATE LIMITED
Application ANDA065421
Marketing category ANDA
Marketing start 2015-01-21
Marketing end 0000-00-00
Substance RIFAMPIN
Active strength 600 mg/10mL
Pharmacologic classes Rifamycin Antibacterial [EPC],Rifamycins [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065421-001 RIFAMPIN RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065421-001 AP
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 2 · 42 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 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065421-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2008-05-22 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Rifampin RIFAMPIN Mylan Institutional LLC 8be91604-d7cd-4f2b-997d-e3364e4092e5 2026-05-05 Warnings, Adverse reactions Exact identifier application applno (ANDA): 065421 application number: ANDA065421
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82449-802-01 82449080201 1 VIAL in 1 CARTON (82449-802-01) > 10 mL in 1 VIAL 1 vial 2015-01-21 0000-00-00 No No Current