Rifampin

Product NDC
0185-0801
11-digit product format
001850801
Labeler code
0185
Product ID
0185-0801_b57ddd24-b8a3-4b5e-950b-4c5f772b91b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rifampin
Dosage form
CAPSULE
Route
ORAL
Labeler
Eon Labs, Inc.
Application
ANDA064150
Marketing category
ANDA
Marketing start
1998-01-02
Marketing end
2025-06-30
Substance
RIFAMPIN
Active strength
150 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0185-0801DDiscontinued by firm2026-08-17
excluded packagepackage0185-08010185-0801-01DDiscontinued by firm2026-08-17
excluded packagepackage0185-08010185-0801-05DDiscontinued by firm2026-08-17
excluded packagepackage0185-08010185-0801-30DDiscontinued by firm2026-08-17

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 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-0801-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-0801-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0185-0801-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-0801-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-0801-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0185-0801-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-0801-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0185-0801-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-0801-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0185-0801-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-0801-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0185-0801-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-0801-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0185-0801-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-0801-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0185-0801-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-0801-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0185-0801-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-0801-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0185-0801-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-0801-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0185-0801-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-0801-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0185-0801-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0185-0801-05557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A064150-001RIFAMPINRIFAMPIN300MGCAPSULE / ORALAB1997-05-28
A064150-002RIFAMPINRIFAMPIN150MGCAPSULE / ORALAB1998-01-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A064150-001AB
A064150-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064150-001RIFAMPIN300MGCAPSULE / ORALAB1997-05-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A064150-002RIFAMPIN150MGCAPSULE / ORALAB1998-01-02bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A064150-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A064150-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A064150-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A064150-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064150-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064150-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064150-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A064150-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064150-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064150-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064150-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064150-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064150-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064150-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064150-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064150-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064150-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064150-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064150-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064150-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064150-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A064150-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064150-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064150-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064150-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064150-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064150-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064150-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064150-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A064150-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064150-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064150-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064150-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A064150-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064150-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A064150-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064150-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A064150-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064150-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A064150-002AB1bb7c543d1eb4…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0185-0801-01EA - Each0185-08015a2718df-10f2-4533-8bea-572b8b36fb6612012-07-24
0185-0801-30EA - Each0185-08014fc465e6-68ad-4734-86d4-c93e482237a912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIFAMPINACTIVE INGREDIENTVJT6J7R4TRRIFAMPIN CAPSULE [EON LABS, INC.]6
RIFAMPINACTIVE MOIETYVJT6J7R4TRRIFAMPIN CAPSULE [EON LABS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIFAMPIN CAPSULE [EON LABS, INC.]6
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHRIFAMPIN CAPSULE [EON LABS, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRIFAMPIN CAPSULE [EON LABS, INC.]6
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0RIFAMPIN CAPSULE [EON LABS, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRIFAMPIN CAPSULE [EON LABS, INC.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRIFAMPIN CAPSULE [EON LABS, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARIFAMPIN CAPSULE [EON LABS, INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RIFAMPIN CAPSULE [EON LABS, INC.]6
GELATININACTIVE INGREDIENT2G86QN327LRIFAMPIN CAPSULE [EON LABS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIFAMPIN CAPSULE [EON LABS, INC.]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3RIFAMPIN CAPSULE [EON LABS, INC.]6
SHELLACINACTIVE INGREDIENT46N107B71ORIFAMPIN CAPSULE [EON LABS, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIFAMPIN CAPSULE [EON LABS, INC.]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EURIFAMPIN CAPSULE [EON LABS, INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIFAMPIN CAPSULE [EON LABS, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1URIFAMPIN CAPSULE [EON LABS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRIFAMPIN CAPSULE [EON LABS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0185-0801RIFAMPIN CAPSULE [EON LABS, INC.]18Legacy NDC20220405_55816042-946d-4bec-9461-bd998628ff45.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RIFAMPINRIFAMPINCoupler LLC410a314f-83bf-d9b3-e063-6294a90a872c2025-10-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064150
application number: ANDA064150
RIFAMPINRIFAMPINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS28109dee-3e5e-492b-b7d9-9ba46c0b53242025-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064150
application number: ANDA064150
RIFAMPINRIFAMPINEPIC PHARMA, LLC0391f1e1-70d4-4b15-8b58-055bb6a385b82023-12-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064150
application number: ANDA064150

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0185-0801-0100185080101100 CAPSULE in 1 BOTTLE (0185-0801-01) 100 capsule1998-01-020000-00-00NoNoCurrent
0185-0801-300018508013030 CAPSULE in 1 BOTTLE (0185-0801-30) 30 capsule1998-01-020000-00-00NoNoCurrent