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 01:54:01

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0013-0102-01EA - Each0013-01025fa718d1-06d6-4cb8-a812-7efbfbd0aa6612012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0013-01020013-0102-01

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N007073-001AZULFIDINESULFASALAZINE500MGTABLET / ORALABRLD, RS, Approved before 1982
N007073-002AZULFIDINE EN-TABSSULFASALAZINE500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N007073-001AB
N007073-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-0684e616aacf4f…
2026-08-18 06:07:402026-07N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N007073-001AZULFIDINE500MGTABLET / ORALABRLD, RS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N007073-002AZULFIDINE EN-TABS500MGTABLET, DELAYED RELEASE / ORALABRLD, RS1983-04-0674a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N007073-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N007073-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N007073-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N007073-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N007073-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N007073-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N007073-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N007073-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N007073-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N007073-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N007073-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N007073-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N007073-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N007073-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N007073-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N007073-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N007073-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N007073-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N007073-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N007073-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N007073-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N007073-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N007073-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N007073-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N007073-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N007073-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N007073-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N007073-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N007073-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N007073-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N007073-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N007073-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N007073-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N007073-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N007073-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N007073-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N007073-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N007073-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N007073-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N007073-002AB174a2ff9319b5…

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
Azulfidine EN-tabsSULFASALAZINEPfizer Laboratories Div Pfizer Incb9ef541a-93c8-4428-ba45-398aa0b327d12026-05-29Warnings, Adverse reactionsExact identifier
ndc (package): 0013-0102-01
ndc11 (package): 00013010201

Reported adverse events (FAERS/openFDA)#

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