Home NDC 52959-653 Rifampin
Product NDC 52959-653
11-digit product format 529590653
Labeler code 52959
Product ID 52959-653_0a0823ba-8547-46bb-84de-076196f6a913
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rifampin
Dosage form CAPSULE, COATED
Route ORAL
Labeler H.J. Harkins Company, Inc.
Application ANDA065028
Marketing category ANDA
Marketing start 2001-07-01
Marketing end 0000-00-00
Substance RIFAMPIN
Active strength 300 mg/1
Pharmacologic classes Rifamycin Antibacterial [EPC],Rifamycins [CS]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 of 2 · 110 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A065028-001 RIFAMPIN RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 A065028-002 RIFAMPIN RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14
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 · 86 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 2026-09-14 22:38:34 2026-08 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL 2001-03-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL 2001-03-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52959-653-10 Rifampin 10 in 1 BOTTLE, PLASTIC CAPSULE, COATED 10 2 52959-653-20 Rifampin 20 in 1 BOTTLE, PLASTIC CAPSULE, COATED 20 2 52959-653-30 Rifampin 30 in 1 BOTTLE, PLASTIC CAPSULE, COATED 30 2 52959-653-40 Rifampin 40 in 1 BOTTLE, PLASTIC CAPSULE, COATED 40 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RIFAMPIN ACTIVE INGREDIENT VJT6J7R4TR RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 RIFAMPIN ACTIVE MOIETY VJT6J7R4TR RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 AMMONIA INACTIVE INGREDIENT 5138Q19F1X RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52959-653 RIFAMPIN CAPSULE, COATED [H.J. HARKINS COMPANY, INC.] 2 Legacy NDC, 4 package rows 20120120_3cc0bcd2-37d7-4a7b-808b-980d864281af.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 52959-653-10 52959065310 10 in 1 BOTTLE, PLASTIC Historical 52959-653-20 52959065320 20 in 1 BOTTLE, PLASTIC Historical 52959-653-30 52959065330 30 in 1 BOTTLE, PLASTIC Historical 52959-653-40 52959065340 40 in 1 BOTTLE, PLASTIC Historical