Home NDC 70954-892 Rifampin
Product NDC 70954-892
11-digit product format 709540892
Labeler code 70954
Product ID 70954-892_b389b1a3-672f-47e3-916c-4a9c044b211b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rifampin
Dosage form CAPSULE
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA219918
Marketing category ANDA
Marketing start 2026-07-20
Substance RIFAMPIN
Active strength 150 mg/1
Pharmacologic classes Rifamycin Antibacterial [EPC], Rifamycins [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A219918-001 RIFAMPIN RIFAMPIN 150MG CAPSULE / ORAL AB 2026-06-29 A219918-002 RIFAMPIN RIFAMPIN 300MG CAPSULE / ORAL AB 2026-06-29
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.
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 2026-09-14 22:38:34 2026-08 A219918-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2026-06-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219918-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2026-06-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219918-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2026-06-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219918-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2026-06-29 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219918-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2026-06-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219918-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2026-06-29 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Rifampin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIFAMPIN 150 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198201 Internal RxNorm lookup 198202 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70954-892-10 70954089210 30 CAPSULE in 1 BOTTLE (70954-892-10) 30 capsule 2026-07-20 No No Current 70954-892-20 70954089220 100 CAPSULE in 1 BOTTLE (70954-892-20) 100 capsule 2026-07-20 No No Current