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 1 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 2 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 2022-03-09 01:35 UTC 2022-03 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 3f01610625f2…2019-12-14 00:12 UTC 2019-12 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 b00525d2431f…2019-09-15 20:21 UTC 2019-09 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 ea99ee380514…2019-07-19 19:46 UTC 2019-07 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 053a50430f4f…2023-05-13 08:27 UTC 2023-05 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 3a93d1ddd44b…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065028-001 RIFAMPIN 150MG CAPSULE / ORAL AB 2001-03-14 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A065028-002 RIFAMPIN 300MG CAPSULE / ORAL AB 2001-03-14 f41ea6bd6efb…
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