Orphenadrine Citrate
- Product NDC
- 63629-1564
- 11-digit product format
- 636291564
- Labeler code
- 63629
- Product ID
- 63629-1564_1a6afbdf-cba9-4ed0-9d82-1f47fb32dd7a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ORPHENADRINE CITRATE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA040284
- Marketing category
- ANDA
- Marketing start
- 1998-06-19
- Substance
- ORPHENADRINE CITRATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Dataset | Scope | Package NDC |
|---|---|---|
| excluded product | product | |
| excluded package | package | 63629-1564-7 |
| excluded package | package | 63629-1564-5 |
| excluded package | package | 63629-1564-0 |
| excluded package | package | 63629-1564-4 |
| excluded package | package | 63629-1564-2 |
| excluded package | package | 63629-1564-9 |
| excluded package | package | 63629-1564-8 |
| excluded package | package | 63629-1564-3 |
| excluded package | package | 63629-1564-6 |
| excluded package | package | 63629-1564-1 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040284-001 | ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040284-001 | 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 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 1998-06-19 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040284-001 | ORPHENADRINE CITRATE | 100MG | TABLET, EXTENDED RELEASE / ORAL | AB | 1998-06-19 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040284-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040284-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040284-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040284-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040284-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040284-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040284-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040284-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040284-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040284-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040284-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040284-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040284-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040284-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040284-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040284-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040284-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040284-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A040284-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040284-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040284-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040284-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040284-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040284-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040284-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A040284-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040284-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040284-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040284-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040284-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040284-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040284-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040284-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040284-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040284-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040284-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040284-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040284-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040284-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040284-001 | AB | 1 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Orphenadrine Citrate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ORPHENADRINE CITRATE | 100 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| X0A40N8I4S | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 994521 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8408d24e-3948-548d-bb12-b1edf0c05e12 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63629-1564-0 | Orphenadrine Citrate | 56 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 56 | 19 | |
| 63629-1564-1 | Orphenadrine Citrate | 20 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 20 | 19 | |
| 63629-1564-2 | Orphenadrine Citrate | 60 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 60 | 19 | |
| 63629-1564-3 | Orphenadrine Citrate | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | 19 | |
| 63629-1564-4 | Orphenadrine Citrate | 90 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 90 | 19 | |
| 63629-1564-5 | Orphenadrine Citrate | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | 19 | |
| 63629-1564-6 | Orphenadrine Citrate | 28 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 28 | 19 | |
| 63629-1564-7 | Orphenadrine Citrate | 45 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 45 | 19 | |
| 63629-1564-8 | Orphenadrine Citrate | 14 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 14 | 19 | |
| 63629-1564-9 | Orphenadrine Citrate | 120 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 120 | 19 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63629-1564-1 | EA - Each | 63629-1564 | 368749c3-ec9a-4b58-aaba-77979e91db49 | 1 | 2012-07-24 |
| 63629-1564-2 | EA - Each | 63629-1564 | fa6318ab-80ec-4a33-82b4-2261379b4ae7 | 1 | 2012-07-24 |
| 63629-1564-3 | EA - Each | 63629-1564 | 5ab3c22b-89aa-4a8a-85cb-535afcadaf2b | 1 | 2015-02-02 |
| 63629-1564-4 | EA - Each | 63629-1564 | 043817cb-d043-4733-9992-80c0d613f6f1 | 1 | 2015-02-02 |
| 63629-1564-5 | EA - Each | 63629-1564 | 004f21d9-27d5-4a22-9aab-6c263951035d | 1 | 2015-02-02 |
| 63629-1564-6 | EA - Each | 63629-1564 | 2ce06f16-66ca-489d-a947-ccbdf20c726d | 1 | 2015-02-02 |
| 63629-1564-7 | EA - Each | 63629-1564 | 3d78d3bf-358a-4508-b13c-3774a731eeba | 1 | 2015-02-02 |
| 63629-1564-8 | EA - Each | 63629-1564 | 87d21394-af31-4cb9-ba3d-242a9461d378 | 1 | 2015-02-02 |
| 63629-1564-9 | EA - Each | 63629-1564 | 5cf24f4e-b535-4928-9204-f8b519b9cae3 | 1 | 2015-02-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| ORPHENADRINE CITRATE | ACTIVE INGREDIENT | X0A40N8I4S | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 2 | |
| ORPHENADRINE | ACTIVE MOIETY | AL805O9OG9 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 63629-1564 | ORPHENADRINE CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 19 | Current NDC, Legacy NDC, 10 package rows | 20240829_8408d24e-3948-548d-bb12-b1edf0c05e12.zip |
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 |
|---|---|---|---|---|---|---|
| Orphenadrine Citrate | ORPHENADRINE CITRATE | St. Mary's Medical Park Pharmacy | 59000b66-166e-75d2-e053-2a91aa0af3c0 | 2026-06-26 | Warnings, Adverse reactions | 040284 ANDA040284 |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | REMEDYREPACK INC. | 7905e80f-b60b-48e8-8e63-a3e50211bfe4 | 2026-04-28 | Warnings, Adverse reactions | 040284 ANDA040284 |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | Bryant Ranch Prepack | 1b4e379e-8051-421f-a0f4-ad9e6fb9476a | 2026-02-26 | Warnings, Adverse reactions | 040284 ANDA040284 |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | A-S Medication Solutions | 80ef7fb4-7c50-4d25-915e-f9d4a2ccd199 | 2026-01-20 | Warnings, Adverse reactions | 040284 ANDA040284 |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | PD-Rx Pharmaceuticals, Inc. | 87d78229-f022-4b42-a03c-4e6a985c714f | 2026-01-07 | Warnings, Adverse reactions | 040284 ANDA040284 |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | Northwind Health Company, LLC | 106be130-b4f8-5ca1-e063-6294a90a1590 | 2026-01-01 | Warnings, Adverse reactions | 040284 ANDA040284 |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | Lupin Pharmaceuticals, Inc. | 7b76c8a7-dd0c-481c-8299-26dfd38ce066 | 2025-09-10 | Warnings, Adverse reactions | 040284 ANDA040284 |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Preferred Pharmaceuticals, Inc. | 8ca9438d-320f-4499-aee7-6b8ca7cccc65 | 2025-09-04 | Warnings, Adverse reactions | 040284 ANDA040284 |
| Orphenadrine Citrate ER | ORPHENADRINE CITRATE | Advanced Rx Pharmacy of Tennessee, LLC | b5a6846a-ebb3-1fdd-e053-2a95a90a4130 | 2024-12-31 | Warnings, Adverse reactions | 040284 ANDA040284 |
| ORPHENADRINE CITRATE | ORPHENADRINE CITRATE | Advanced Rx Pharmacy of Tennessee, LLC | fc63d413-39bd-409d-e053-6294a90a1463 | 2024-12-31 | Warnings, Adverse reactions | 040284 ANDA040284 |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Lake Erie Medical DBA Quality Care Products LLC | 233915f1-7d58-4b4c-a2bb-e73179d61d07 | 2024-12-16 | Warnings, Adverse reactions | 040284 ANDA040284 |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Bryant Ranch Prepack | 8408d24e-3948-548d-bb12-b1edf0c05e12 | 2024-08-27 | Warnings, Adverse reactions | 040284 ANDA040284 63629-1564 |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | NuCare Pharmaceuticals, Inc. | 3eb1b1cc-ed7a-6f0f-e054-00144ff88e88 | 2024-08-13 | Warnings, Adverse reactions | 040284 ANDA040284 |
| Orphenadrine Citrate | ORPHENADRINE CITRATE | Proficient Rx LP | cf620257-7497-44c1-9853-87f96d262fbd | 2023-12-01 | Warnings, Adverse reactions | 040284 ANDA040284 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 994521 | orphenadrine citrate 100 MG 12HR Extended Release Oral Tablet | PSN | 8408d24e-3948-548d-bb12-b1edf0c05e12 | 19 |
| 994521 | 12 HR orphenadrine citrate 100 MG Extended Release Oral Tablet | SCD | 8408d24e-3948-548d-bb12-b1edf0c05e12 | 19 |
| 994521 | orphenadrine citrate 100 MG 12 HR Extended Release Oral Tablet | SY | 8408d24e-3948-548d-bb12-b1edf0c05e12 | 19 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-1564-0 | 63629156400 | 56 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-0) | 2006-09-22 | 0000-00-00 | No | No | Current |
| 63629-1564-1 | 63629156401 | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-1) | 2006-09-22 | 0000-00-00 | No | No | Current |
| 63629-1564-2 | 63629156402 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-2) | 2006-09-22 | 0000-00-00 | No | No | Current |
| 63629-1564-3 | 63629156403 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-3) | 2006-09-22 | 0000-00-00 | No | No | Current |
| 63629-1564-4 | 63629156404 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-4) | 2006-09-22 | 0000-00-00 | No | No | Current |
| 63629-1564-5 | 63629156405 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-5) | 2006-09-22 | 0000-00-00 | No | No | Current |
| 63629-1564-6 | 63629156406 | 28 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-6) | 2006-09-22 | 0000-00-00 | No | No | Current |
| 63629-1564-7 | 63629156407 | 45 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-7) | 2006-09-22 | 0000-00-00 | No | No | Current |
| 63629-1564-8 | 63629156408 | 14 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-8) | 2006-09-22 | 0000-00-00 | No | No | Current |
| 63629-1564-9 | 63629156409 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-1564-9) | 2006-09-22 | 0000-00-00 | No | No | Current |