Home NDC 0068-0597 Rifadin IV
Product NDC 0068-0597
11-digit product format 000680597
Labeler code 0068
Product ID 0068-0597_d5ee3f24-779e-4fd0-ba26-e870acbd1111
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rifampin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Sanofi-Aventis U.S. LLC
Application NDA050627
Marketing category NDA
Marketing start 1989-05-25
Marketing end 2026-09-30
Substance RIFAMPIN
Active strength 600 mg/10mL
Pharmacologic classes Rifamycin Antibacterial [EPC], Rifamycins [CS]
NDC exclude flag No
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 N050627-001 RIFADIN RIFAMPIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050627-001 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 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050627-001 RIFADIN 600MG/VIAL INJECTABLE / INJECTION AP RLD, RS 1989-05-25 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 Rifadin IV Active Ingredients# Ingredient, Strength table Ingredient Strength RIFAMPIN 600 mg/10mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 207436 Internal RxNorm lookup 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 0068-0597-01 Rifadin IV 10 mL in 1 VIAL, GLASS INJECTION, POWDER, LYOPHILIZED, 10 52 0068-0597-01 Rifadin IV 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 52
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded rifampin ACTIVE INGREDIENT VJT6J7R4TR RIFADIN (RIFAMPIN) CAPSULE RIFADIN IV (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 9 rifampin ACTIVE MOIETY VJT6J7R4TR RIFADIN (RIFAMPIN) CAPSULE RIFADIN IV (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 9 D&C Red No. 28 INACTIVE INGREDIENT 767IP0Y5NH RIFADIN (RIFAMPIN) CAPSULE RIFADIN IV (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 9 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD RIFADIN (RIFAMPIN) CAPSULE RIFADIN IV (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 9 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA RIFADIN (RIFAMPIN) CAPSULE RIFADIN IV (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 9 gelatin INACTIVE INGREDIENT 2G86QN327L RIFADIN (RIFAMPIN) CAPSULE RIFADIN IV (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 9 magnesium stearate INACTIVE INGREDIENT 70097M6I30 RIFADIN (RIFAMPIN) CAPSULE RIFADIN IV (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 9 sodium formaldehyde sulfoxylate INACTIVE INGREDIENT X4ZGP7K714 RIFADIN (RIFAMPIN) CAPSULE RIFADIN IV (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 9 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I RIFADIN (RIFAMPIN) CAPSULE RIFADIN IV (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 9 starch, corn INACTIVE INGREDIENT O8232NY3SJ RIFADIN (RIFAMPIN) CAPSULE RIFADIN IV (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 9 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP RIFADIN (RIFAMPIN) CAPSULE RIFADIN IV (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0068-0597 RIFADIN IV (RIFAMPIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 50 Current NDC, Legacy NDC, 2 package rows 20250519_036ab68e-5085-4edc-bd83-784b43d64eab.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 Marketing start Marketing end Sample Exclude flag Status 0068-0597-01 00068059701 1 VIAL, GLASS in 1 CARTON (0068-0597-01) / 10 mL in 1 VIAL, GLASS 1989-05-25 2026-09-30 No No Current