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 02:37:03

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-029-10EA - Each21695-029c2993399-e981-47a6-91de-ae3009bbb25512012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-02921695-029-10

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
N021368-001CIALISTADALAFIL5MGTABLET / ORALAB1RLD2003-11-21
N021368-002CIALISTADALAFIL10MGTABLET / ORALAB1RLD2003-11-21
N021368-003CIALISTADALAFIL20MGTABLET / ORALAB1RLD, RS2003-11-21
N021368-004CIALISTADALAFIL2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-01-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N021368-001AB1
N021368-002AB1
N021368-003AB1

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 22:38:342026-08N021368-001CIALIS5MGTABLET / ORALAB1RLD2003-11-2184e616aacf4f…
2026-09-14 22:38:342026-08N021368-002CIALIS10MGTABLET / ORALAB1RLD2003-11-2184e616aacf4f…
2026-09-14 22:38:342026-08N021368-003CIALIS20MGTABLET / ORALAB1RLD, RS2003-11-2184e616aacf4f…
2026-09-14 22:38:342026-08N021368-004CIALIS2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-01-0784e616aacf4f…
2026-08-18 06:07:402026-07N021368-001CIALIS5MGTABLET / ORALAB1RLD2003-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021368-002CIALIS10MGTABLET / ORALAB1RLD2003-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021368-003CIALIS20MGTABLET / ORALAB1RLD, RS2003-11-21caaa826d4ba7…
2026-08-18 06:07:402026-07N021368-004CIALIS2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-01-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021368-001CIALIS5MGTABLET / ORALAB1RLD2003-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021368-002CIALIS10MGTABLET / ORALAB1RLD2003-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021368-003CIALIS20MGTABLET / ORALAB1RLD, RS2003-11-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021368-004CIALIS2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2008-01-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021368-001CIALIS5MGTABLET / ORALAB1RLD2003-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021368-002CIALIS10MGTABLET / ORALAB1RLD2003-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021368-003CIALIS20MGTABLET / ORALAB1RLD, RS2003-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021368-004CIALIS2.5MGTABLET / ORALRLD2008-01-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08N021368-001CIALIS5MGTABLET / ORALAB1RLD2003-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021368-002CIALIS10MGTABLET / ORALAB1RLD2003-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021368-003CIALIS20MGTABLET / ORALAB1RLD, RS2003-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021368-004CIALIS2.5MGTABLET / ORALRLD2008-01-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021368-001CIALIS5MGTABLET / ORALAB1RLD2003-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021368-002CIALIS10MGTABLET / ORALAB1RLD2003-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021368-003CIALIS20MGTABLET / ORALAB1RLD, RS2003-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021368-004CIALIS2.5MGTABLET / ORALRLD2008-01-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021368-001CIALIS5MGTABLET / ORALAB1RLD2003-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021368-002CIALIS10MGTABLET / ORALAB1RLD2003-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021368-003CIALIS20MGTABLET / ORALAB1RLD, RS2003-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021368-004CIALIS2.5MGTABLET / ORALRLD2008-01-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021368-001CIALIS5MGTABLET / ORALAB1RLD2003-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021368-002CIALIS10MGTABLET / ORALAB1RLD2003-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021368-003CIALIS20MGTABLET / ORALAB1RLD, RS2003-11-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021368-004CIALIS2.5MGTABLET / ORALRLD2008-01-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021368-001CIALIS5MGTABLET / ORALAB1RLD2003-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021368-002CIALIS10MGTABLET / ORALAB1RLD2003-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021368-003CIALIS20MGTABLET / ORALAB1RLD, RS2003-11-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021368-004CIALIS2.5MGTABLET / ORALRLD2008-01-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021368-001CIALIS5MGTABLET / ORALAB1RLD2003-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021368-002CIALIS10MGTABLET / ORALAB1RLD2003-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021368-003CIALIS20MGTABLET / ORALAB1RLD, RS2003-11-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021368-004CIALIS2.5MGTABLET / ORALAB1RLD2008-01-075bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N021368-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021368-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08N021368-003AB1184e616aacf4f…
2026-08-18 06:07:402026-07N021368-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N021368-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07N021368-003AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021368-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021368-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021368-003AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021368-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021368-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021368-003AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021368-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021368-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021368-003AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021368-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021368-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021368-003AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021368-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021368-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021368-003AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021368-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021368-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021368-003AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021368-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021368-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021368-003AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021368-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021368-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021368-003AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021368-004AB115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021368-001AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021368-002AB11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021368-003AB11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021368-001AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10N021368-002AB11d06236e962d9…
2024-10-29 15:01 UTC2024-10N021368-003AB11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021368-001AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021368-002AB1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021368-003AB1179d66fd596c7…

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021368-00169431662020-04-26U-118474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-00169431662020-04-26U-61474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-00169431662020-04-26U-15574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-0016943166*PED2020-10-26Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-00269431662020-04-26U-15574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-00269431662020-04-26U-61474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-0026943166*PED2020-10-26Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-00369431662020-04-26U-61474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-00371829582020-04-26U-155Drug product, Delist requested74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-0036943166*PED2020-10-26Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-0037182958*PED2020-10-26Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-00469431662020-04-26U-15574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-00471829582020-04-26U-155Drug product, Delist requested74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-0046943166*PED2020-10-26Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-0047182958*PED2020-10-26Pediatric extension74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021368-00169431662020-04-26U-11848869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-00169431662020-04-26U-6148869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-00169431662020-04-26U-1558869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-0016943166*PED2020-10-26Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-00269431662020-04-26U-1558869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-00269431662020-04-26U-6148869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-0026943166*PED2020-10-26Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-00369431662020-04-26U-6148869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-0036943166*PED2020-10-26Pediatric extension8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-00469431662020-04-26U-1558869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-0046943166*PED2020-10-26Pediatric extension8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021368-00169431662020-04-26U-1184c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021368-00169431662020-04-26U-614c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021368-00169431662020-04-26U-155c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021368-0016943166*PED2020-10-26Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021368-00269431662020-04-26U-155c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021368-00269431662020-04-26U-614c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021368-0026943166*PED2020-10-26Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021368-00369431662020-04-26U-614c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021368-0036943166*PED2020-10-26Pediatric extensionc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021368-00469431662020-04-26U-155c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021368-0046943166*PED2020-10-26Pediatric extensionc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021368-00169431662020-04-26U-11843f01610625f2…
2019-12-14 00:12 UTC2019-12N021368-00169431662020-04-26U-6143f01610625f2…
2019-12-14 00:12 UTC2019-12N021368-00169431662020-04-26U-1553f01610625f2…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N021368-001M-2192021-02-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-001PED2021-08-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-002M-2192021-02-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-002PED2021-08-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-003M-2192021-02-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-003PED2021-08-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-004M-2192021-02-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021368-004PED2021-08-1574a2ff9319b5…
2021-12-28 21:50 UTC2021-12N021368-001M-2192021-02-15782e0a99824c…
2021-12-28 21:50 UTC2021-12N021368-001PED2021-08-15782e0a99824c…
2021-12-28 21:50 UTC2021-12N021368-002M-2192021-02-15782e0a99824c…
2021-12-28 21:50 UTC2021-12N021368-002PED2021-08-15782e0a99824c…
2021-12-28 21:50 UTC2021-12N021368-003M-2192021-02-15782e0a99824c…
2021-12-28 21:50 UTC2021-12N021368-003PED2021-08-15782e0a99824c…
2021-12-28 21:50 UTC2021-12N021368-004M-2192021-02-15782e0a99824c…
2021-12-28 21:50 UTC2021-12N021368-004PED2021-08-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021368-001M-2192021-02-1587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021368-001PED2021-08-1587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021368-002M-2192021-02-1587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021368-002PED2021-08-1587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021368-003M-2192021-02-1587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021368-003PED2021-08-1587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021368-004M-2192021-02-1587673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021368-004PED2021-08-1587673890dc5c…
2021-03-12 10:30 UTC2021-03N021368-001M-2192021-02-155aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021368-001PED2021-08-155aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021368-002M-2192021-02-155aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021368-002PED2021-08-155aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021368-003M-2192021-02-155aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021368-003PED2021-08-155aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021368-004M-2192021-02-155aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021368-004PED2021-08-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021368-001M-2192021-02-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-001PED2021-08-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-002M-2192021-02-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-002PED2021-08-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-003M-2192021-02-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-003PED2021-08-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-004M-2192021-02-158869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021368-004PED2021-08-158869cabd3fbd…

Reported adverse events (FAERS/openFDA)#

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