Home NDC 63323-351 Rifampin
Product NDC 63323-351
11-digit product format 633230351
Labeler code 63323
Product ID 63323-351_60eb9c46-3c34-455b-a740-c03884565072
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RIFAMPIN
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA091181
Marketing category ANDA
Marketing start 2014-08-21
Substance RIFAMPIN
Active strength 600 mg/1
Pharmacologic classes Rifamycin Antibacterial [EPC], Rifamycins [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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091181-001 RIFAMPIN RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091181-001 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 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091181-001 RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP 2014-08-21 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Rifampin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIFAMPIN 600 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VJT6J7R4TR Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 312821 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 63323-351-20 Rifampin 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 8 63323-351-20 Rifampin 1 in 1 BOX INJECTION, POWDER, LYOPHILIZED, 1 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RIFAMPIN ACTIVE INGREDIENT VJT6J7R4TR RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 RIFAMPIN ACTIVE MOIETY VJT6J7R4TR RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM FORMALDEHYDE SULFOXYLATE INACTIVE INGREDIENT X4ZGP7K714 RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I RIFAMPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-351 RIFAMPIN (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 8 Current NDC, Legacy NDC, 2 package rows 20221013_a1f9f1e2-dfc0-4d31-a13b-b656d897b791.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 · 1 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 63323-351-20 63323035120 1 VIAL in 1 BOX (63323-351-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1 vial 2014-08-21 0000-00-00 No No Current