Home NDC 0904-7315 rifampin
Product NDC 0904-7315
11-digit product format 009047315
Labeler code 0904
Product ID 0904-7315_de94fe08-b966-4803-b90e-0455f3955a7e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rifampin
Dosage form CAPSULE
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA090034
Marketing category ANDA
Marketing start 2025-02-25
Substance RIFAMPIN
Active strength 300 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 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 A090034-001 RIFAMPIN RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 A090034-002 RIFAMPIN RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21
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 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2013-08-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090034-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2013-08-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090034-002 RIFAMPIN 300MG CAPSULE / ORAL AB RS 2013-08-21 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 rifampin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RIFAMPIN 300 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 198202 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 0904-7315-61 rifampin 1 in 1 BLISTER PACK CAPSULE 1 4 0904-7315-61 rifampin 100 in 1 CARTON CAPSULE 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7315 RIFAMPIN CAPSULE [MAJOR PHARMACEUTICALS] 1 Current NDC, 2 package rows 20250228_3f3534c1-95e4-4bdd-b044-9026e4addf0c.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0904-7315-61 00904731561 100 BLISTER PACK in 1 CARTON (0904-7315-61) / 1 CAPSULE in 1 BLISTER PACK 100 blister pack 2025-02-25 No No Current