Rifampin

Product NDC
63629-4042
11-digit product format
636294042
Labeler code
63629
Product ID
63629-4042_839d0e00-074c-43fc-b1b2-59c696c7a505
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rifampin
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA064150
Marketing category
ANDA
Marketing start
1997-05-28
Marketing end
2025-06-30
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

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-4042DDiscontinued by firm2026-08-17
excluded packagepackage63629-404263629-4042-1DDiscontinued by firm2026-08-17
excluded packagepackage63629-404263629-4042-2DDiscontinued by firm2026-08-17
excluded packagepackage63629-404263629-4042-3DDiscontinued by firm2026-08-17
excluded packagepackage63629-404263629-4042-4DDiscontinued 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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4042-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4042-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4042-4DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4042-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4042-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4042-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4042-4DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4042-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-4042-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-4042-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-4042-3IInactivated by FDA9bebd1f3094a…5416666fcb17…

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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4042-1EA - Each63629-4042d4e5a201-04ef-4211-8cae-ec2167b4988d12012-07-24
63629-4042-2EA - Each63629-40427cee188a-e4be-47a8-a028-803cfee4081912012-07-24
63629-4042-3EA - Each63629-40421fb11a85-7e80-4d22-beac-42c05505ac1412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RIFAMPINACTIVE INGREDIENTVJT6J7R4TRRIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
RIFAMPINACTIVE MOIETYVJT6J7R4TRRIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0RIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDRIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOARIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357RIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
GELATININACTIVE INGREDIENT2G86QN327LRIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EURIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JRIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJRIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
TALCINACTIVE INGREDIENT7SEV7J4R1URIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRIFAMPIN CAPSULE [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4042RIFAMPIN CAPSULE [BRYANT RANCH PREPACK]8Legacy NDC20220505_0609253c-505b-c6d0-241e-90ffdba25ca2.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
63629-4042-16362940420130 CAPSULE in 1 BOTTLE (63629-4042-1) 30 capsule2009-08-172025-06-30NoNoCurrent
63629-4042-26362940420260 CAPSULE in 1 BOTTLE (63629-4042-2) 60 capsule2021-12-222025-06-30NoNoCurrent
63629-4042-36362940420320 CAPSULE in 1 BOTTLE (63629-4042-3) 20 capsule2009-09-042025-06-30NoNoCurrent
63629-4042-46362940420410 CAPSULE in 1 BOTTLE (63629-4042-4) 10 capsule2011-06-242025-06-30NoNoCurrent