National Council for Prescription Drug Programs indexing - billing unit

Manufacturer
National Council for Prescription Drug Programs
Effective date
2012-07-24
Label type
Indexing - Billing Unit
Version
1
Source
full-release
Hydrated at
2026-06-05 01:39:22

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0003-3624-12EA - Each0003-362447ea6086-905b-4eee-9d72-db6d98996db812012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0003-36240003-3624-12

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021567-001REYATAZATAZANAVIR SULFATEEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-20
N021567-002REYATAZATAZANAVIR SULFATEEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-20
N021567-003REYATAZATAZANAVIR SULFATEEQ 200MG BASECAPSULE / ORALABRLD2003-06-20
N021567-004REYATAZATAZANAVIR SULFATEEQ 300MG BASECAPSULE / ORALABRLD, RS2006-10-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021567-003AB
N021567-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021567-001REYATAZEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N021567-002REYATAZEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N021567-003REYATAZEQ 200MG BASECAPSULE / ORALABRLD2003-06-2084e616aacf4f…
2026-09-14 22:38:342026-08N021567-004REYATAZEQ 300MG BASECAPSULE / ORALABRLD, RS2006-10-1684e616aacf4f…
2026-08-18 06:07:402026-07N021567-001REYATAZEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07N021567-002REYATAZEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07N021567-003REYATAZEQ 200MG BASECAPSULE / ORALABRLD2003-06-20caaa826d4ba7…
2026-08-18 06:07:402026-07N021567-004REYATAZEQ 300MG BASECAPSULE / ORALABRLD, RS2006-10-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021567-001REYATAZEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021567-002REYATAZEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021567-003REYATAZEQ 200MG BASECAPSULE / ORALABRLD2003-06-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021567-004REYATAZEQ 300MG BASECAPSULE / ORALABRLD, RS2006-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021567-001REYATAZEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021567-002REYATAZEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021567-003REYATAZEQ 200MG BASECAPSULE / ORALABRLD2003-06-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021567-004REYATAZEQ 300MG BASECAPSULE / ORALABRLD, RS2006-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021567-001REYATAZEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021567-002REYATAZEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021567-003REYATAZEQ 200MG BASECAPSULE / ORALABRLD2003-06-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021567-004REYATAZEQ 300MG BASECAPSULE / ORALABRLD, RS2006-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021567-001REYATAZEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021567-002REYATAZEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021567-003REYATAZEQ 200MG BASECAPSULE / ORALABRLD2003-06-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021567-004REYATAZEQ 300MG BASECAPSULE / ORALABRLD, RS2006-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021567-001REYATAZEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021567-002REYATAZEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021567-003REYATAZEQ 200MG BASECAPSULE / ORALABRLD2003-06-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021567-004REYATAZEQ 300MG BASECAPSULE / ORALABRLD, RS2006-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021567-001REYATAZEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021567-002REYATAZEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021567-003REYATAZEQ 200MG BASECAPSULE / ORALABRLD2003-06-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021567-004REYATAZEQ 300MG BASECAPSULE / ORALABRLD, RS2006-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021567-001REYATAZEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021567-002REYATAZEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021567-003REYATAZEQ 200MG BASECAPSULE / ORALABRLD2003-06-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021567-004REYATAZEQ 300MG BASECAPSULE / ORALABRLD, RS2006-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021567-001REYATAZEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021567-002REYATAZEQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2003-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021567-003REYATAZEQ 200MG BASECAPSULE / ORALABRLD2003-06-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021567-004REYATAZEQ 300MG BASECAPSULE / ORALABRLD, RS2006-10-165bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 98 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021567-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N021567-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N021567-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021567-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021567-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021567-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021567-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021567-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021567-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021567-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021567-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021567-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021567-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021567-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021567-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021567-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021567-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021567-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021567-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021567-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021567-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021567-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021567-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021567-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021567-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021567-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021567-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021567-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021567-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021567-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021567-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021567-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021567-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021567-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021567-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021567-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021567-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021567-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021567-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021567-004AB14b0b4de00fa7…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021567-0016087383*PED2019-06-21Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021567-0026087383*PED2019-06-21Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021567-0036087383*PED2019-06-21Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021567-0046087383*PED2019-06-21Pediatric extension74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021567-0016087383*PED2019-06-21Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021567-0026087383*PED2019-06-21Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021567-0036087383*PED2019-06-21Pediatric extension3f01610625f2…
2019-12-14 00:12 UTC2019-12N021567-0046087383*PED2019-06-21Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021567-0016087383*PED2019-06-21Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021567-0026087383*PED2019-06-21Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021567-0036087383*PED2019-06-21Pediatric extensionb00525d2431f…
2019-09-15 20:21 UTC2019-09N021567-0046087383*PED2019-06-21Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021567-0016087383*PED2019-06-21Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N021567-0026087383*PED2019-06-21Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N021567-0036087383*PED2019-06-21Pediatric extensionea99ee380514…
2019-07-19 19:46 UTC2019-07N021567-0046087383*PED2019-06-21Pediatric extensionea99ee380514…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.165cff62-b284-4a27-a65d-9ec8a5bfcdd82024-12-05Warnings, Adverse reactionsExact identifier
ndc (package): 0003-3624-12
ndc11 (package): 00003362412

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.