Home NDC 49702-222 ZIAGEN
Product NDC 49702-222
11-digit product format 497020222
Labeler code 49702
Product ID 49702-222_b0a93ca3-a511-4567-8875-24abb03dd28c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name abacavir sulfate
Dosage form SOLUTION
Route ORAL
Labeler ViiV Healthcare Company
Application NDA020978
Marketing category NDA
Marketing start 1999-01-28
Substance ABACAVIR SULFATE
Active strength 20 mg/mL
Pharmacologic classes Cytochrome P450 1A1 Inhibitors [MoA], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020978-001 ZIAGEN ABACAVIR SULFATE EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020978-001 AA
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 2 · 41 observed states.
Captured, Edition, Application-product table 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 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020978-001 ZIAGEN EQ 20MG BASE/ML SOLUTION / ORAL AA RLD, RS 1998-12-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N020978-001 6641843 2019-02-04 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020978-001 6641843*PED 2019-08-04 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N020978-001 6641843 2019-02-04 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N020978-001 6641843*PED 2019-08-04 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020978-001 6641843 2019-02-04 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N020978-001 6641843*PED 2019-08-04 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020978-001 6641843 2019-02-04 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N020978-001 6641843*PED 2019-08-04 Pediatric extension ea99ee380514…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ZIAGEN ABACAVIR SULFATE ViiV Healthcare Company ca73b519-015a-436d-aa3c-af53492825a1 2023-09-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020978 application number: NDA020978 ndc (product): 49702-222
Additional Listing Data#
Finished product Yes
Brand name base ZIAGEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ABACAVIR SULFATE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J220T4J9Q2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 213461 Internal RxNorm lookup 242680 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49702-222-48 ZIAGEN 1 in 1 CARTON SOLUTION 1 32 49702-222-48 ZIAGEN 240 mL in 1 BOTTLE SOLUTION 240 32
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ABACAVIR SULFATE ACTIVE INGREDIENT J220T4J9Q2 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 ABACAVIR ACTIVE MOIETY WR2TIP26VS ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 SORBITOL INACTIVE INGREDIENT 506T60A25R ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17 WATER INACTIVE INGREDIENT 059QF0KO0R ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49702-222 ZIAGEN (ABACAVIR SULFATE) TABLET, FILM COATED ZIAGEN (ABACAVIR SULFATE) SOLUTION [VIIV HEALTHCARE COMPANY] 31 Current NDC, Legacy NDC, 2 package rows 20240608_ca73b519-015a-436d-aa3c-af53492825a1.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49702-222-48 49702022248 1 BOTTLE in 1 CARTON (49702-222-48) / 240 mL in 1 BOTTLE 1 bottle 1999-01-28 0000-00-00 No No Current