Home NDC 0527-1315 Rifampin
Product NDC 0527-1315
11-digit product format 005271315
Labeler code 0527
Product ID 0527-1315_57ec8c8d-ff55-4e8d-b023-ef646a1fd1e7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rifampin
Dosage form CAPSULE
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA065390
Marketing category ANDA
Marketing start 2008-04-20
Marketing end 2022-10-31
Substance RIFAMPIN
Active strength 300 mg/1
Pharmacologic classes Rifamycin Antibacterial [EPC], Rifamycins [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 82 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 2026-02-19 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…2021-12-28 21:50 UTC 2021-12 A065390-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2008-03-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065390-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2008-03-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RIFAMPIN ACTIVE INGREDIENT VJT6J7R4TR RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 RIFAMPIN ACTIVE MOIETY VJT6J7R4TR RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 ALCOHOL INACTIVE INGREDIENT 3K9958V90M RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 GELATIN INACTIVE INGREDIENT 2G86QN327L RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 SHELLAC INACTIVE INGREDIENT 46N107B71O RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 TALC INACTIVE INGREDIENT 7SEV7J4R1U RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RIFAMPIN CAPSULE [LANNETT COMPANY, INC.] 18 RIFAMPIN ACTIVE INGREDIENT VJT6J7R4TR RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 RIFAMPIN ACTIVE MOIETY VJT6J7R4TR RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 ALCOHOL INACTIVE INGREDIENT 3K9958V90M RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 SHELLAC INACTIVE INGREDIENT 46N107B71O RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 TALC INACTIVE INGREDIENT 7SEV7J4R1U RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RIFAMPIN CAPSULE [AMERICAN HEALTH PACKAGING] 6 RIFAMPIN ACTIVE INGREDIENT VJT6J7R4TR RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 RIFAMPIN ACTIVE INGREDIENT VJT6J7R4TR RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 RIFAMPIN ACTIVE MOIETY VJT6J7R4TR RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 RIFAMPIN ACTIVE MOIETY VJT6J7R4TR RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 METHYL ALCOHOL INACTIVE INGREDIENT Y4S76JWI15 RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RIFAMPIN CAPSULE [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RIFAMPIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1
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 0527-1315-01 00527131501 100 CAPSULE in 1 BOTTLE (0527-1315-01) 100 capsule 2008-04-20 0000-00-00 No No Current 0527-1315-06 00527131506 60 CAPSULE in 1 BOTTLE (0527-1315-06) 60 capsule 2008-04-20 0000-00-00 No No Current 0527-1315-30 00527131530 30 CAPSULE in 1 BOTTLE (0527-1315-30) 30 capsule 2008-04-20 0000-00-00 No No Current