Zithromax
- Product NDC
- 0069-4061
- Requested package NDC
- 0069-4061-01
- 11-digit product format
- 000694061
- Labeler code
- 0069
- Product ID
- 0069-4061_1c5f0fcc-88ce-47e9-a128-b7326b7a5a02
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA050711
- Marketing category
- NDA
- Marketing start
- 2019-05-17
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [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 |
|---|---|---|---|---|---|---|---|
| N050711-001 | ZITHROMAX | AZITHROMYCIN | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N050711-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050711-001 | ZITHROMAX | EQ 250MG BASE | TABLET / ORAL | AB | RLD | 1996-07-18 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N050711-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N050711-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050711-001 | AB | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N050711-001 | AB | 1 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Zithromax
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AZITHROMYCIN DIHYDRATE | 250 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5FD1131I7S | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 105260 | Internal RxNorm lookup |
| 141963 | Internal RxNorm lookup |
| 211307 | Internal RxNorm lookup |
| 212446 | Internal RxNorm lookup |
| 226827 | Internal RxNorm lookup |
| 248656 | Internal RxNorm lookup |
| 308459 | Internal RxNorm lookup |
| 308460 | Internal RxNorm lookup |
| 749780 | Internal RxNorm lookup |
| 749783 | Internal RxNorm lookup |
| 750149 | Internal RxNorm lookup |
| 750157 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| db52b91e-79f7-4cc1-9564-f2eee8e31c45 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401 | Product name | 9 | 20200616 |
| a2cbe82e-b432-4f71-954b-75e9214e8567 | Product name | 3 | 20200612 |
| 371533fa-efb3-4c48-b5e4-60179db407f3 | Product name | 3 | 20190124 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0069-4061-01 | Zithromax | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 48 | |
| 0069-4061-75 | Zithromax | 3 in 1 BOX | TABLET, FILM COATED | 3 | 48 | |
| 0069-4061-75 | Zithromax | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | 48 | |
| 0069-4061-89 | Zithromax | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 48 | |
| 0069-4061-89 | Zithromax | 50 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 50 | 48 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0069-4061-01 | EA - Each | 0069-4061 | 053241b5-341a-4b69-b2c5-7bea7ca7ef1f | 1 | 2020-05-08 |
| 0069-4061-89 | EA - Each | 0069-4061 | 724749d2-695d-4392-8081-e7818b11a03f | 1 | 2019-10-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0069-4061 | ZITHROMAX (AZITHROMYCIN DIHYDRATE) TABLET, FILM COATED ZITHROMAX (AZITHROMYCIN DIHYDRATE) POWDER, FOR SUSPENSION [PFIZER LABORATORIES DIV PFIZER INC] | 47 | Current NDC, Legacy NDC, 5 package rows | 20250205_db52b91e-79f7-4cc1-9564-f2eee8e31c45.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 |
|---|---|---|---|---|---|---|
| Zithromax | AZITHROMYCIN DIHYDRATE | Pfizer Laboratories Div Pfizer Inc | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 2026-07-24 | Warnings, Adverse reactions | 050711 NDA050711 0069-4061-01 0069-4061 00069406101 |
| Zithromax | AZITHROMYCIN DIHYDRATE | Redpharm Drug | 3ddecd25-dc32-a2af-e063-6294a90a526d | 2025-09-03 | Warnings, Adverse reactions | 050711 NDA050711 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 750157 | {3 (azithromycin 500 MG Oral Tablet [Zithromax]) } Pack [TRI-PAK] | BPCK | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 750149 | {6 (azithromycin 250 MG Oral Tablet [Zithromax]) } Pack [Z-PAK] | BPCK | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 749780 | {3 (azithromycin 500 MG Oral Tablet) } Pack | GPCK | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 749783 | {6 (azithromycin 250 MG Oral Tablet) } Pack | GPCK | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 308459 | azithromycin 100 MG in 5 mL Oral Suspension | PSN | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 141963 | azithromycin 200 MG in 5 mL Oral Suspension | PSN | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 308460 | azithromycin 250 MG Oral Tablet | PSN | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | PSN | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 248656 | azithromycin 500 MG Oral Tablet | PSN | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | PSN | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 750149 | Z-PAK 6 Count Pack | PSN | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 211307 | Zithromax 100 MG in 5 mL Oral Suspension | PSN | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 105260 | Zithromax 200 MG in 5 mL Oral Suspension | PSN | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 212446 | Zithromax 250 MG Oral Tablet | PSN | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 226827 | Zithromax 500 MG Oral Tablet | PSN | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 750157 | Zithromax TRI-PAK, 3 Count | PSN | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 211307 | azithromycin 20 MG/ML Oral Suspension [Zithromax] | SBD | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 212446 | azithromycin 250 MG Oral Tablet [Zithromax] | SBD | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 105260 | azithromycin 40 MG/ML Oral Suspension [Zithromax] | SBD | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 226827 | azithromycin 500 MG Oral Tablet [Zithromax] | SBD | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 308459 | azithromycin 20 MG/ML Oral Suspension | SCD | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 308460 | azithromycin 250 MG Oral Tablet | SCD | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 141963 | azithromycin 40 MG/ML Oral Suspension | SCD | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 248656 | azithromycin 500 MG Oral Tablet | SCD | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 308459 | azithromycin 100 MG per 5 ML Oral Suspension | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 141963 | azithromycin 1200 MG per 30 ML Oral Suspension | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 141963 | azithromycin 200 MG per 5 ML Oral Suspension | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 248656 | azithromycin 500 MG (as azithromycin monohydrate) Oral Tablet | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 749780 | azithromycin 500 MG Oral Tablet 3 Count Pack | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 141963 | azithromycin 600 MG per 15 ML Oral Suspension | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 750157 | TRI-PAK | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 750149 | Z-PAK | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 211307 | Zithromax 100 MG per 5 ML Oral Suspension | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 211307 | Zithromax 20 MG/ML Oral Suspension | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 105260 | Zithromax 200 MG per 5 ML Oral Suspension | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 212446 | Zithromax 250 MG Oral Tablet | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 105260 | Zithromax 40 MG/ML Oral Suspension | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 226827 | Zithromax 500 MG Oral Tablet | SY | db52b91e-79f7-4cc1-9564-f2eee8e31c45 | 48 |
| 750149 | {6 (azithromycin 250 MG Oral Tablet [Zithromax]) } Pack [Z-PAK] | BPCK | 1ebe30e0-271d-79a0-e063-6394a90abcf2 | 1 |
| 749783 | {6 (azithromycin 250 MG Oral Tablet) } Pack | GPCK | 1ebe30e0-271d-79a0-e063-6394a90abcf2 | 1 |
| 308460 | azithromycin 250 MG Oral Tablet | PSN | 1ebe30e0-271d-79a0-e063-6394a90abcf2 | 1 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | PSN | 1ebe30e0-271d-79a0-e063-6394a90abcf2 | 1 |
| 750149 | Z-PAK 6 Count Pack | PSN | 1ebe30e0-271d-79a0-e063-6394a90abcf2 | 1 |
| 212446 | Zithromax 250 MG Oral Tablet | PSN | 1ebe30e0-271d-79a0-e063-6394a90abcf2 | 1 |
| 212446 | azithromycin 250 MG Oral Tablet [Zithromax] | SBD | 1ebe30e0-271d-79a0-e063-6394a90abcf2 | 1 |
| 308460 | azithromycin 250 MG Oral Tablet | SCD | 1ebe30e0-271d-79a0-e063-6394a90abcf2 | 1 |
| 749783 | azithromycin 250 MG Oral Tablet 6 Count Pack | SY | 1ebe30e0-271d-79a0-e063-6394a90abcf2 | 1 |
| 750149 | Z-PAK | SY | 1ebe30e0-271d-79a0-e063-6394a90abcf2 | 1 |
| 212446 | Zithromax 250 MG Oral Tablet | SY | 1ebe30e0-271d-79a0-e063-6394a90abcf2 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0069-4061-01 | 00069406101 | 30 TABLET, FILM COATED in 1 BOTTLE (0069-4061-01) | 2020-05-04 | 0000-00-00 | No | No | Current |