Diclofenac Sodium Misoprostol
- Product NDC
- 72162-2518
- 11-digit product format
- 721622518
- Labeler code
- 72162
- Product ID
- 72162-2518_4f4755a3-4605-4418-8456-4b917ad15c32
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- diclofenac sodium and misoprostol
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205143
- Marketing category
- ANDA
- Marketing start
- 2021-07-15
- Substance
- DICLOFENAC SODIUM; MISOPROSTOL
- Active strength
- 50; 200 mg/1; ug/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | |
| A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | DICLOFENAC SODIUM; MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205143-001 | AB |
| A205143-002 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205143-001 | DICLOFENAC SODIUM AND MISOPROSTOL | 50MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205143-002 | DICLOFENAC SODIUM AND MISOPROSTOL | 75MG;0.2MG | TABLET, DELAYED RELEASE / ORAL | AB | 2020-02-19 | 87673890dc5c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A205143-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205143-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205143-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205143-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205143-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205143-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205143-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205143-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205143-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205143-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205143-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205143-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205143-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205143-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205143-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205143-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205143-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205143-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A205143-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A205143-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205143-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205143-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205143-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205143-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205143-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205143-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A205143-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A205143-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205143-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205143-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A205143-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A205143-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A205143-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A205143-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A205143-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A205143-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A205143-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A205143-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205143-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205143-002 | AB | 1 | 87673890dc5c… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium Misoprostol
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DICLOFENAC SODIUM | 50 mg/1 |
| MISOPROSTOL | 200 ug/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| QTG126297Q | Internal UNII lookup |
| 0E43V0BB57 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 857706 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| de4c02a5-87e8-42f5-a9ff-f409ff9e6d62 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 111d457e-3138-4512-b0ba-d0cd760c4055 | Product name | 3 | 20250225 |
| 0426261e-1bb9-b78b-abd2-80da765a7e3e | Product name | 2 | 20240513 |
| 7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7 | Product name | 5 | 20240320 |
| 73109aa8-3e7c-b7a0-fb29-6f84db91e7d9 | Product name | 3 | 20231221 |
| 0ac2f11f-f58d-baf2-71a0-680993b48a61 | Product name | 2 | 20231211 |
| 855d63c3-b090-4636-8fc7-6d39ad23c44f | Product name | 1 | 20230829 |
| bb58f410-04be-65dd-9211-e89ead899698 | Product name | 6 | 20230323 |
| 0fcbc38a-8b29-3348-1cef-5222ea53484f | Product name | 4 | 20220516 |
| c4e1eedc-aca2-4551-8382-89144ed9d049 | Product name | 3 | 20220126 |
| 8d368a34-1453-43ea-828d-0dbcd72b8794 | Product name | 8 | 20210622 |
| d6bab9d2-edce-a213-4796-226ab15472c3 | Product name | 6 | 20200616 |
| 2487e6ef-d419-42fc-aaf8-7acc805d2370 | Product name | 2 | 20170718 |
| e071c814-e5e7-e7ed-ec76-428765d9c66b | Product name | 2 | 20151120 |
| 93148e06-b8d7-4e6c-853e-62f807d17fbb | Product name | 1 | 20151014 |
| dbb00be6-fb1c-4b0a-a770-31f7e05e247e | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72162-2518-6 | Diclofenac Sodium Misoprostol | 60 in 1 BOTTLE | TABLET, DELAYED RELEASE | 60 | 101 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72162-2518-6 | EA - Each | 72162-2518 | c5518d36-ce90-4812-b1b4-ff7e1b417ed7 | 1 | 2025-08-11 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Diclofenac Sodium Misoprostol | DICLOFENAC SODIUM AND MISOPROSTOL | Bryant Ranch Prepack | 6865a5cf-3263-44b5-96d9-7a7a4c6e1c05 | 2026-05-11 | Boxed warning, Warnings, Adverse reactions | 205143 ANDA205143 |
| Diclofenac Sodium Misoprostol | DICLOFENAC SODIUM AND MISOPROSTOL | Bryant Ranch Prepack | de4c02a5-87e8-42f5-a9ff-f409ff9e6d62 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 205143 ANDA205143 72162-2518 |
| Diclofenac Sodium Misoprostol | DICLOFENAC SODIUM AND MISOPROSTOL | Bryant Ranch Prepack | 6f9684f7-f39a-4f5e-9fd4-ed140fae206b | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 205143 ANDA205143 |
| Diclofenac Sodium Misoprostol | DICLOFENAC SODIUM AND MISOPROSTOL | Nivagen Pharmaceuticals, Inc. | 2acf46ac-8ba8-444d-b421-19d5ad49644c | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 205143 ANDA205143 |
| Diclofenac Sodium Misoprostol | DICLOFENAC SODIUM AND MISOPROSTOL | Proficient Rx LP | 33f7db0b-f049-4d2e-abf5-4db97222e175 | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 205143 ANDA205143 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 857706 | diclofenac sodium 50 MG / miSOPROStol 0.2 MG Delayed Release Oral Tablet | PSN | de4c02a5-87e8-42f5-a9ff-f409ff9e6d62 | 101 |
| 857706 | diclofenac sodium 50 MG / misoprostol 0.2 MG Delayed Release Oral Tablet | SCD | de4c02a5-87e8-42f5-a9ff-f409ff9e6d62 | 101 |
| 857706 | diclofenac sodium (enteric coated core) 50 MG / misoprostol (non-enteric coated mantle) 200 MCG Oral Tablet | SY | de4c02a5-87e8-42f5-a9ff-f409ff9e6d62 | 101 |
| 857706 | diclofenac sodium 50 MG / misoprostol 200 MCG Delayed Release Oral Tablet | SY | de4c02a5-87e8-42f5-a9ff-f409ff9e6d62 | 101 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 72162-2518-6 | 72162251806 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72162-2518-6) | 2021-07-15 | No | No | Current |