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 01:30:17

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-6346-02ML - Milliliter0338-634635bc0e14-8e62-4c48-abec-e52bbfddc22712012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0338-63460338-6346-02

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
N016673-001DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016673-003DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N016673-001AP
N016673-003AP

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 22:38:342026-08N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-3084e616aacf4f…
2026-08-18 06:07:402026-07N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016673-001DEXTROSE 5% IN PLASTIC CONTAINER5GM/100MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N016673-003DEXTROSE 5% IN PLASTIC CONTAINER50MG/MLINJECTABLE / INJECTIONAPRLD, RS1985-10-3074a2ff9319b5…

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 22:38:342026-08N016673-001AP184e616aacf4f…
2026-09-14 22:38:342026-08N016673-003AP184e616aacf4f…
2026-08-18 06:07:402026-07N016673-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016673-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016673-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016673-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016673-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016673-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016673-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016673-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016673-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016673-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016673-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016673-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016673-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016673-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016673-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016673-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016673-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016673-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016673-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016673-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016673-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10N016673-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016673-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016673-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016673-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016673-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016673-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016673-003AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016673-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N016673-003AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016673-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016673-003AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016673-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N016673-003AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016673-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N016673-003AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016673-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N016673-003AP174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

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