Home NDC 62135-316 Rifampin
Product NDC 62135-316
11-digit product format 621350316
Labeler code 62135
Product ID 62135-316_f9244302-8654-6016-e053-6294a90ad64c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rifampin
Dosage form CAPSULE
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA065390
Marketing category ANDA
Marketing start 2008-04-20
Substance RIFAMPIN
Active strength 300 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065390-001 RIFAMPIN RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 A065390-002 RIFAMPIN RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28
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 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 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 2026-12-31 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 · 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62135-316-60 Rifampin 60 in 1 BOTTLE CAPSULE 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-316 RIFAMPIN CAPSULE [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20230415_4c39ee75-ae96-456d-bf47-16d49865345e.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 Sample Exclude flag Status 62135-316-60 62135031660 60 CAPSULE in 1 BOTTLE (62135-316-60) 60 capsule 2023-04-05 No No Current