Rifampin

Product NDC
63739-415
11-digit product format
637390415
Labeler code
63739
Product ID
63739-415_bdaa99c9-0d93-74aa-e053-2a95a90afd63
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rifampin
Dosage form
CAPSULE
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA064150
Marketing category
ANDA
Marketing start
1997-05-28
Marketing end
0000-00-00
Substance
RIFAMPIN
Active strength
300 mg/1
Pharmacologic classes
Rifamycin Antibacterial [EPC],Rifamycins [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63739-415DDiscontinued by firm2026-08-17
excluded packagepackage63739-41563739-415-10DDiscontinued 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 · 24 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 packagepackage63739-415-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63739-415-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63739-415-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63739-415-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63739-415-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63739-415-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63739-415-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63739-415-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63739-415-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63739-415-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63739-415-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63739-415-10557ba5c1ecfa…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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-415-102020-07-22C16284748780-1ab0e2407-2f63-f274-e053-dbdaa90a6471Rifampin Capsules, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-415-10EA - Each63739-415cfbc9f0d-9577-4e28-9d7f-1a95dd9528e412013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIFAMPINACTIVE INGREDIENTVJT6J7R4TRRIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
RIFAMPINACTIVE MOIETYVJT6J7R4TRRIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0RIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
GELATININACTIVE INGREDIENT2G86QN327LRIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EURIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
TALCINACTIVE INGREDIENT7SEV7J4R1URIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRIFAMPIN CAPSULE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]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 · 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
63739-415-106373904151010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-415-10) > 10 CAPSULE in 1 BLISTER PACK10 blister pack1997-05-280000-00-00NoNoCurrent